Notification

Notice Ref No: QN-CPS-2018-113 ClinChem fully automated

Version 2

Document Date: 21-11-2019/ Application

PRODUCT: Tina-quant Albumin Gen.2

α-Amylase EPS ver.2
α-Amylase EPS Pancreatic
Bicarbonate Liquid
Calcium Gen.2
C‑Reactive Protein Gen.3
Creatinine plus ver.2
Creatinine Jaffé Gen.2
Ethanol Gen.2
Fructosamine
Glucose HK
Magnesium Gen.2
Phosphate (Inorganic) ver.2
Total Protein Urine/CSF Gen.3
Uric Acid ver.2
Refer to table 1,2 and 3 for reagent catalogue numbers, platforms
and Instruction for Use versions.

COMPONENT cobas c 111 analyzer

cobas c 311 analyzer a308
cobas c 501 module
cobas c 503 module a309
cobas c 502 module a2324
cobas c 701 module a310
cobas c 702 module a2492
MODULAR ANALYTICS P-MODULE
MODULAR ANALYTICS D-MODULE
COBAS INTEGRA® 400 plus

EXECUTIVE SUMMARY: New endogenous interferences on selected

ClinChem and HIA assays in serum/plasma and
urine without medical risk V2

ACTION: Customer action

CONTACTS: Centro de Excelencia en Atención al Cliente CEAC:

50815864 & 01800-7188853/54
SWA - Product and Specialist App – Hub México

QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1

Dear Customer:

With the introduction of the cobas c 503 platform, selected endogenous and drug interferences in
serum/plasma, urine and CSF (cerebrospinal fluid) were assessed for their potential risk on all Roche tests
and corresponding platforms.

This Notification summarizes the identified endogenous and individual drug interferences where a
medicalrisk to patients and users is unlikely.

All Instructions for Use (IFU) will be updated for the cobas c 311/501/502 and cobas c 701/702 platforms
only and are attached to this Notification.

An update is now available for COBAS INTEGRA® 400 plus and cobas c 111. In addition, the reduced
concentration of the urea interference claim for all cobas c analyzers for AMYL2/AMY-P is stated.

For further background information, refer to Addendum I and II of this Notification.

Investigations
Table 1: Assessed new interferences in serum/plasma:
Affected IFUs with test catalogue numbers, updated IFU versions and specified interferences

Catalogue no. Systems IFU IFU Methyldopa

Test short IGG
version version (drug
name (≤60 g/L)*
current new interferent)

05401470190 CREP2 cobas c 111 9 10 Methyldopa

causes artificially
cobas c low creatinine
03263991190 CREP2 311/501/502 13 14 xxx results
COBAS
INTEGRA 11 12
400 Plus

cobas c 10
05168589190 CREP2 11 (1) xxx
701/702 (n.a.)

11775685216 CREA plus 22 n.a. xxx

MODULAR
11875566216
P,D
11875582216
cobas c
04537939190 FRA 7 8 xxx. Methyldopa
311/501/502**
causes artificially
cobas c
05171962190 FRA 4 5 xxx. high
701/702
fructosamine
11930010216 FRUC MODULAR P 13 n.a. xxx results

05455308190 CO2-L cobas c 111 4 5 ≤35 xxx

cobas c
03289923190 CO2-L 311/501/502 11 12 ≤35 xxx
COBAS
INTEGRA 7 8
400 plus

QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1

 CO2-L cobas c
06407102190 10 11 ≤35 xxx
(700) 701/702

CO2-L cobas c
05446376191 10 11 ≤35 xxx
(1100) 701/702
03289885190
CO2-L MODULAR P 12 n.a. ≤35 xxx
03289907190
cobas c
CRPL3 311/501/502 9 10 ≤50 xxx
04956842190
cobas c
05172373190 CRPL3 701/702 8 9 ≤50 xxx

04956885190
04956923190 CRPL3 MODULAR P; 9 n.a. ≤50 xxx
P,D
04995554190
cobas c
D Bili 311/501/502 (14) (15) ≤30 xxx
04924495190
cobas c
DBili 701/702 (6) (7) ≤30 xxx
05975921190**
*defined maximum endogenous interferent concentration (see Addendum II chapter 6)
** COBAS INTEGRA® 400 plus FRUC V5 IFU already contains the methyldopa interference

 xxx means that no interference was measured below the max. interferent concentration
 USA IFU version in brackets, where applicable
 FRUC serum/plasma applications are not available on cobas c 111
 There is no CRPL3 serum/plasma application on COBAS INTEGRA® 400 plus nor on cobas c 111

Table 2 Assessed new interferences in urine

Affected IFUs with test catalogue numbers, updated IFU versions and specified interferences

Catalogue no. Systems Phosphate Urea Hemolysis

Test IFU IFU
(≤130 (≤3000 (≤750
Short version version
mmol/L)* mmol/L)* mg/dL)*
name current new

cobas c
05401500190 ALBT2 10 11 ≤70 ≤800 xxx
111
cobas c
04469658190 ALBT2 311/501/502 11 12 (11) ≤70 ≤800 xxx
COBAS
INTEGRA® 9 10
400 plus
cobas c
05167043190 ALBT2 7 8 (7) ≤70 ≤800 xxx
701/702
03576108190 MODULAR
Albumin 17 (6) n.a. ≤70 ≤800 xxx
04999622190 P

cobas c
05401496190 AMYL2 5 6 ≤70 ≤1500 ≤500
111

QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1

 cobas c
03183742122 AMYL2 311/501/502 10 11 ≤70 ≤1500 ≤500
COBAS
INTEGRA® 6 7
400 plus
cobas c
08056811190 AMYL2 1 2 ≤70 ≤1500 ≤500
503

cobas c
05167027190 AMYL2 6 7 ≤70 ≤1500 ≤500
701/702
MODULAR
11876473316 AMYL 18 n.a. ≤70 ≤1500 ≤500
P

cobas c
10759350190 AMY-P 4 5 ≤60 ≤1500 ≤500
111

20766623322 AMY-P cobas c ≤60 ≤1500 ≤500

12 13
311/501/502
COBAS 6 7
INTEGRA®
400 plus

cobas c
08056820190 AMY-P 1 2 ≤60 ≤1500 ≤500
503

05167035190 AMY-P cobas c 6 7 ≤60 ≤1500 ≤500

701/702
MODULAR
11876562316 P-AMYL P 17 n.a. ≤60 ≤1500 ≤500

05061504190 CA2 cobas c 4 5 xxx ≤1600 xxx

111

05061482190 CA2 cobas c 3 4 xxx ≤1600 xxx

311/501/
502 3 4
COBAS
INTEGRA
400 plus

05168449190 CA2 cobas c 3 4 xxx ≤1600 xxx

701/702
05061431190 MODULAR
05061458190 CA2 P,D 5 n.a. xxx ≤1600 xxx

05061466190 MODULAR
05061474190 CA2 D 5 n.a. xxx ≤1600 xxx

05401470190 CREP2 cobas c 9 10 (Draft) xxx ≤2100 xxx

111

03263991190 CREP2 cobas c 13 14 xxx ≤2100 xxx

311/501/
502 11 12 (Draft)
COBAS
INTEGRA
400 plus

QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1

 Catalogue no. Systems Phosphate Urea Hemolysis
Test IFU IFU
(≤130 (≤3000 (≤750
Short version version
mmol/L)* mmol/L)* mg/dL)*
name current new

cobas c
05168589190 CREP2 10 11 (V1) xxx ≤2100 xxx
701/702
11775685216
CREA MODULAR
11875566216 22 n.a. xxx ≤2100 xxx
plus P,D
11875582216
cobas c
05401755 190 CREJ2 9 10 xxx ≤2100 xxx
111
cobas c
04810716190 CREJ2 311/501/502 18 19 xxx ≤2100 xxx
COBAS
INTEGRA® 9 10
400 plus
cobas c
06407137190 CREJ2 12 13 xxx ≤2100 xxx
701/702
11875418216
MODULAR
11875663216 CREA 21 n.a. xxx ≤2100 xxx
P
11929941216
cobas c
03183777190 ETOH2 311/501/502 14 15 xxx ≤1800 xxx
COBAS
INTEGRA® 5 6
400 plus
cobas c
05967104190 ETOH2 9 10 xxx ≤1800 xxx
701/702
11776312190 MODULAR
ETH 11 n.a. xxx ≤1800 xxx
11868152190 P
cobas c
04404483190 GLUC3 311/501/502 12 13 (13) xxx ≤1800 xxx
COBAS
INTEGRA® 10 11
400 plus
cobas c
05168791190 GLUC3 6 7 (6) xxx ≤1800 xxx
701/702
11876899216
MODULAR
11929534216 GLU 20 n.a. xxx ≤1800 xxx
P; P,D
11929542216
11876899216
MODULAR
11929534216 GLUH2 5 n.a. xxx ≤1800 xxx
P
11929542216
cobas c
06481647190 MG2 5 6 xxx ≤1500 xxx
311/501/502

cobas c
06407358190 MG2 13 14 xxx ≤1500 xxx
701/702
11551353216
MODULAR
11929615216 Mg 21 n.a. xxx ≤1500 xxx
P; P,D
11929623216
cobas c
05401780190 PHOS2 5 6 xxx ≤1500 xxx
111
QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1
 cobas c
03183793122 PHOS2 311/501/502 7 8 xxx ≤1500 xxx
COBAS
INTEGRA® 11 12
400 plus

cobas c
05171377190 PHOS2 8 9 xxx ≤1500 xxx
701/702
11730347216
MODULAR
11875949216 PHOS2 15 n.a. xxx ≤1500 xxx
P; P,D
11875965216
cobas c
03333825190 TPUC3 311/501/502 12 13 (12) xxx ≤1300 xxx
COBAS
INTEGRA® 13 (8) 14 (9)
400 plus
cobas c
05171954190 TPUC3 7 8 (7) xxx ≤1300 xxx
701/702

U/CSF MODULAR
11877801190 16 n.a. xxx ≤1300 xxx
Protein P

cobas c
04657608190 UA2 11 12 xxx ≤2100 xxx
111
cobas c
03183807190 UA2 311/501/502 11 12 xxx ≤2100 xxx
COBAS
INTEGRA® 10 11
400 plus
cobas c
05171857190 UA2 9 10 xxx ≤2100 xxx
701/702
11875426216
MODULAR
11929429216 UA plus 19 n.a. xxx ≤2100 xxx
P; P,D
11929437216
*defined maximum endogenous interferent concentration (see Addendum II chapter 6)

 XXX means that no interference was measured below the max. interferent concentration
 USA IFU version in brackets, where applicable
 Oxalate was measured up to a concentration of 1,5 mmol/L, but no interferences were found for all
listed
 tests
 no interference was found below the max. interferent concentration for Ditaurobilirubin and all
listed tests
 Levels above the max. endogenous interferent concentration are not relevant, because the
probability of
 occurrence of this enormous endogenous concentrations can be neglected
 Adaptation of urea interference specification from 2100 to 1500 for Amylase assays on all
platforms required due to new internal interference measurement results
 Urea interference of 1500 mmol/L already mentioned in V1 of MG2 method sheet for COBAS
INTEGRA® 400 plus / cobas c 111
 ETOH2, GLUC3, TPUC3 and FRUC urine application are not available on cobas c 111

QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1

Table 3: Assessed new interference in CSF

Catalogue no. Test Systems Current New

Ditaurobilirubin
Short IFU IFU
(≤60 mg/dL)*
name version version
cobas c
03333825190 TPUC3 311/501/502 12 13 (12) ≤15
COBAS
INTEGRA® 13 (8) 14 (9)
400 plus
cobas c
05171954190 TPUC3 7 8 ≤15
701/702
U/CSF MODULAR
11877801190 16 n.a. n.a.
Protein P
*defined maximum endogenous interferent concentration (see Addendum II chapter 6)

 XXX means that no interference was measured below the max. interferent concentration

In general:
 The maximum endogenous interferent levels (=recommended CLSI test concentration – common
pathological value) in various body fluids were used to assess the possible interferences of assays.
 It is not intended to add the maximum assay interference level tested to the Limitations-
Interferences section of each IFU, if no impact was found.

Conclusion
In the Serum/plasma Limitations – interference section of the updated IFUs, including COBAS INTEGRA®
400 plus and cobas c 111, the following claims are newly added. These contain threshold plasma
concentrations with no significant test interference up to a deviation of ≤10%. This deviation is based on
the diagnostic cutoff, i.e. decision level and accepted for all Roche platforms:

Interferences in serum/plasma:
CREP2
As tested according to CLSI recommendation Methyldopa causes artificially low creatinine results
FRA
As tested according CLSI recommendation Methyldopa causes artificially high fructosamine results

CO2-L
Immunoglobulins: No significant interference from immunoglobulins up to a concentration of 35 g/L (233.5
μmol/L) (simulated by human immunoglobulin G)
CRPL3
Immunoglobulins: No significant interference from immunoglobulins up to a concentration of 50 g/L (334
μmol/L) (simulated by human immunoglobulin G)

Interferences in urine:
ALBT2
No significant interference from acetone ≤ 60 mmol/L, ammonia chloride ≤ 0.11 mol/L, calcium ≤ 40
mmol/L, creatinine ≤ 0.18 mol/L, γ‑globulin ≤ 500 mg/L, glucose ≤ 0.19 mol/L, phosphate ≤ 70 mmol/L,
urea ≤ 0.8 mol/L, uric acid ≤ 5.95 mmol/L and urobilinogen ≤ 378 μmol/L.
AMYL2
Phosphate: No significant interference from phosphate up to a concentration of 70 mmol/L (217 mg/dL)
Urea: No significant interference from urea up to a concentration of 2100 mmol/L (12612 mg/dL)
Hemolysis: No significant interference up to a hemoglobin concentration of 311 μmol/L or 500 mg/dL

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AMY-P
Phosphate: No significant interference from phosphate up to a concentration of 60 mmol/L (186 mg/dL).
Urea: No significant interference from urea up to a concentration of 2100 mmol/L (12612 mg/dL)
Hemolysis: No significant interference up to a hemoglobin concentration of 311 μmol/L or 500 mg/dL
CA2
Urea: No significant interference from urea up to a concentration of 1600 mmol/L (9610 mg/dL)
CREP2
Urea: No significant interference from urea up to a concentration of 2100 mmol/L (12612 mg/dL)
CREJ2
Urea: No significant interference from urea up to a concentration of 2100 mmol/L (12612 mg/dL)
ETOH2
Urea: No significant interference from urea up to a concentration of 1800 mmol/L (10811 mg/dL)
GLUC3
Urea: No significant interference from urea up to a concentration of 1800 mmol/L (10811 mg/dL)
MG2
Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL)
PHOS2
Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL)
TPUC3
Urea: No significant interference from urea up to a concentration of 1300 mmol/L (7809 mg/dL)
UA2
Urea: No significant interference from urea up to a concentration of 2100 mmol/L (12612 mg/dL)

Interference in CSF:
TPUC3:
Ditaurobilirubin: No significant interference from ditaurobilirubin up to an approximate concentration of
255 μmol/L (15 mg/dL)

In general:
All newly described endogenous interference concentrations for COBAS INTEGRA® 400 plus / cobas c
111 are identical to the interferences already listed in V1 of this Quality Notification for cobas c
311/501/502/c503/701 and 702. The exception is the urea interference concentration for AMYL2 and AMY-
P, which was reduced.

Severity
Serum/plasma
CREP2
The interference is well known, claimed in and covered by the product information of the drug methyldopa.
FRA
Fructosamine assay is not a first line parameter for the assessment of glycemic control, except in cases
when HbA1c measurement is likely to be unreliable (e.g. conditions that affect red blood cell turnover).
Therefore, general population is not affected by the issue. In case of interference of lower concentrations of
methyldopa, no medical risk is likely due to such slight deviations. In case of interference with higher
methyldopa concentrations, the prerequisite for the occurrence of the issue includes combination of several
circumstances (individual with diabetes and condition affecting red blood cell turn-over, treatment with
methyldopa, very recent intake of high doses). Considering the current use of fructosamine, the interfering
concentration of methyldopa needed to cause erroneous elevated fructosamine results and the plasma
half-life of methyldopa, medical risk due to the issue is most unlikely.
CO2-L
An interference with IGG was observed for bicarbonate (CO2-L), leading to deviations of up to -17.1%. The
issue can lead to an underestimation of bicarbonate in serum/plasma. In general, bicarbonate values
outside the reference range might point out at acid-base imbalance and should lead to further medical
testing. However, an immediate medical decision based on slight underestimation of bicarbonate is not
likely. Considering the fact that bicarbonate results should be interpreted in concordance with other
parameters and examination findings, medical risk due to the issue is most unlikely.

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CRPL3
An interference with IGG was observed for CRP, leading to deviations of up to -13.7%. The issue can lead
to an underestimation of CRP in serum/plasma. In general, elevated CRP values can point towards a wide
range of inflammatory diseases and should lead to further medical testing. An immediate medical decision
based on slight underestimation of CRP is not likely. Considering the fact that CRP results should be
interpreted in concordance with other parameters and examination findings, medical risk due to the issue
is most unlikely.

Urine
ALBT2
An interference with phosphate was observed for albumin se in urine, leading to deviations of up to –18.2
%. The issue can lead to an underestimation of urinary albumin. In general, increased urinary albumin
should lead to further investigation whereas therapy will depend on underlying disease. However, it is not
likely that any immediate medical decision will be based on such slight underestimation. Considering the
fact that urinary albumin should be interpreted in concordance with other parameters and examination
findings, medical risk due to the issue is most unlikely.
AMYL2
An interference with phosphate was observed for amylase in urine, leading to deviations of up to -16.2 %.
The issue can lead to an underestimation of urinary amylase. In general, erroneously decreased urinary
amylase levels can further affect estimation of amylase to creatinine ratio. However, it is unlikely that any
immediate medical decision will be based on such slight underestimation. Considering the fact that urinary
amylase should be interpreted in concordance with other parameters and examination findings, medical
risk due to the issue is most unlikely.
An interference with urea was observed for amylase in urine, leading to deviations of up to -12.6 %.
The issue can lead to an underestimation of urinary amylase. In general, erroneously decreased urinary
amylase levels can further affect estimation of amylase to creatinine ratio. However, it is unlikely that any
immediate medical decision will be based on such slight underestimation. Considering the fact that urinary
amylase should be interpreted in concordance with other parameters and examination findings, medical
risk due to the issue is most unlikely.
An interference with hemolysis was observed for amylase in urine, leading to deviations of up to -14.8
%. The issue can lead to an underestimation of urinary amylase. In general, erroneously decreased urinary
amylase levels can further affect estimation of amylase to creatinine ratio. However, it is unlikely that any
immediate medical decision will be based on such slight underestimation. Considering the probable
detectability of the issue (samples with 500 mg/dL Hb are visibly red) and the fact that urinary amylase
results should be interpreted in concordance with other parameters and examination findings, medical risk
due to the issue is most unlikely.
AMY-P
In this case, an interference with phosphate was observed for pancreatic amylase in urine, leading to
deviations of up to –15.5 %. The issue can lead to an underestimation of urinary pancreatic amylase. In
general, erroneously decreased urinary amylase levels can further affect estimation of amylase to creatinine
ratio. However, it is unlikely that any immediate medical decision will be based on such slight
underestimation. Considering the fact that urinary pancreatic amylase should be interpreted in
concordance with other parameters and examination findings, medical risk due to the issue is most
unlikely.
An interference with urea was observed for pancreatic amylase in urine, leading to deviations of up to
-11.6 %. The issue can lead to an underestimation of urinary amylase. In general, erroneously decreased
urinary amylase levels can further affect estimation of amylase to creatinine ratio. However, it is unlikely
that any immediate medical decision will be based on such slight underestimation. Considering the fact
that urinary amylase should be interpreted in concordance with other parameters and examination findings,
medical risk due to the issue is most unlikely.
An interference with hemolysis was observed for pancreatic amylase in urine, leading to deviations of
up to -13.9 %. The issue can lead to an underestimation of urinary pancreatic amylase. In general,
erroneously decreased urinary amylase levels can further affect estimation of amylase to creatinine ratio.
However, it is unlikely that any immediate medical decision will be based on such slight underestimation.
Considering the probable detectability of the issue (samples with 500 mg/dL Hb are visibly red) and the fact
that urinary amylase should be interpreted in concordance with other parameters and examination findings,
medical risk due to the issue is most unlikely.

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CA2
An interference with urea was observed for calcium in urine, leading to deviations of up to -15.3 %.
The issue can lead to an underestimation of urinary calcium. In general, urine calcium measurement is to
aid in the differential diagnosis and in this case, it is not likely that any immediate medical decision will be
based on such slight underestimation. Considering the fact that urinary calcium should be interpreted in
concordance with other parameters and examination findings, medical risk due to the issue is most
unlikely.
CREP2
An interference with urea was observed for creatinine (enzymatic method) in urine, leading to
deviations of up to -11.3 %. The issue can lead to an underestimation of urinary creatinine. In general, an
underestimation of urine creatinine can lead to discrepant normal/lower results, affecting the creatinine
clearance result and, potentially, the interpretation of the glomerular filtration rate. In this case, however,
considering the extent of the observed difference, medical risk due to the issue is most unlikely.
CREJ2
An interference with urea was observed for creatinine (Jaffe) in urine, leading to deviations of up to -11.0
%. The issue can lead to an underestimation of urinary creatinine. In general, an underestimation of urine
creatinine can lead to discrepant normal/lower results, affecting the creatinine clearance result and,
potentially, the interpretation of the glomerular filtration rate. In this case, however, considering the extent
of the observed deviation, medical risk due to the issue is most unlikely.
ETOH2
An interference with urea was observed for ethanol in urine, leading to deviations of up to -12.0 %.
The issue can lead to an underestimation of urinary ethanol. In general, beside the direct demonstration of
ethanol, the available markers of alcohol consumption include the classic indirect markers. As alcohol
biomarker test results should never be interpreted in isolation, it is unlikely that any immediate medical
decision will be based on such slight underestimation. Considering the fact that urinary ethanol results
should be interpreted in concordance with other parameters and examination findings, medical risk due to
the issue is most unlikely.
GLUC3
An interference with urea was observed for glucose in urine, leading to deviations of up to -11.6 %. The
issue can lead to an underestimation of urinary glucose. In general, glucose measurement in urine is used
as a diabetes screening procedure and to aid in the evaluation of glycosuria, to detect renal tubular defects,
and in the management of diabetes mellitus. An immediate medical decision based on slight
underestimation of urinary glucose is not likely. Considering the fact that urinary glucose results should be
interpreted in concordance with other parameters and examination findings, medical risk due to the issue
is most unlikely.
MG2
An interference with urea was observed for magnesium in urine, leading to deviations of up to -14.5
%. The issue can lead to an underestimation of urinary magnesium. In general, urine magnesium
measurement is used to assess the hypomagnesemia and it is not likely that any immediate medical
decision will be based on such slight underestimation. Considering the fact that urinary magnesium should
be interpreted in concordance with other parameters and examination findings, medical risk due to the
issue is most unlikely.
PHOS2
An interference with urea was observed for phosphate in urine, leading to deviations of up to -14.7 %.
The issue can lead to an underestimation of urinary phosphate. In general, urine phosphate measurement
is to assess the phosphate secretion and to investigate the cause of hypophosphatemia. It is unlikely that
any immediate medical decision will be based on such slight underestimation. Considering the fact that
urinary phosphate should be interpreted in concordance with other parameters and examination findings,
medical risk due to the issue is most unlikely.
TPUC3
An interference with urea was observed for total protein in urine, leading to deviations of up to-17.0 %. The
issue can lead to an underestimation of urinary protein. In general, an underestimation of total protein in
urine can lead to discrepant normal/lower result. However, considering the extent of the observed deviation
and the fact that the total protein in urine results should be interpreted in concordance with other
laboratory parameters and diagnostic tests, medical risk due to the issue is most unlikely.
UA2
An interference with urea was observed for uric acid in urine, leading to deviations of up to -13.4 %. The
issue can lead to an underestimation of urinary uric acid. In general, an underestimation of uric acid in
urine can lead to discrepant normal/lower result, potentially affecting further evaluation. However, in this
QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1
case, considering the extent of the observed deviation and the fact that urinary uric acid results should be
interpreted in concordance with other laboratory parameters and diagnostic tests, medical risk due to the
issue is most unlikely.

CSF
TPUC3
An interference with ditaurobilirubin was observed for total protein in CSF, leading to deviations of up to
+15.7 %. The issue can lead to an overestimation of total protein in CSF. In general, CSF protein
measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors and
infections of the central nervous system and elevated results should lead to further examinations. However,
considering the extent of the observed bias and that total protein in CSF is measured in combination with
other parameters, medical risk due to the issue is most unlikely.

Important Information
All IFUs will be updated for the cobas c 311/501/502 and cobas c 701/702 platforms. All IFUs for COBAS
INTEGRA® 400 plus and cobas c 111 will gradually updated by the end of Q1/2020. The printed IFU
versions for cobas c111 are in the kit commencing with the next lots. The updated IFUs will also be
published in eLab Doc.

Due to the phase out of the Roche/Hitachi MODULAR ANALYTICS <P> and <D> analyzers by the end of
Q1/2019, those IFUs will not be updated with the newly measured endogenous interferences. The new
claims on the cobas c systems will also apply to the MODULAR ANALYTICS platform.

With relation to COBAS INTEGRA® 400 plus and cobas c 111, the interference assessments will be
completed in Q2 2019. Depending on the outcome of the assessment, the subsequent updates of the
corresponding Limitations– interference section for COBAS INTEGRA® 400 plus and cobas c 111
platforms will be completed. Roche will inform you accordingly.

Updated e-Library packages containing the updated IFUs for cobas c 311/501/502/701/702 will be
released to the cobas e-Content Portal by December 2018 with reference to this Notification.
Updated e-Library packages containing the updated IFUs for cobas c 311/501/502/503/701/702 for
AMYL2 and AMY-P and for cobas c 311/501/502/701/702 D Bili (USA) will be released to the cobas e-
Content Portal by December 2019 with reference to this Notification

The updated e-packages for some of the applications will have the following additional content and are
referenced as follows:

Product Additional Content

• New endogenous Interferences on selected ClinChem and HIA assays
CREJ2 • CREAJ: Endogenous Interference by Glucose, Pyruvate, and Ascorbic
acid

• Implementation of additional unit

CREP2 NOTE: for cobas c 701/702 the additional unit was already
implemented together with the instrument factor
• New endogenous Interferences on selected ClinChem and HIA assays
• Increased sample volume harmonized with normal sample volume for
on cobas c 701/702

• New endogenous Interferences on selected ClinChem and HIA assays

MG2 • Incomplete SENS Limit information concerning change of reportable
unit

QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1

Please note:
For ALBT2, CA2, CREJ2, CREP2, IGG-2, MG2 the IFUs for cobas c 311/501/502/701/702 systems contain
an additional unit, which is – for technical reasons - NOT implemented in the e-barcode. As a
consequence, the additional unit will be removed again in the next IFU update.

Please do not hesitate to contact us in case of questions regarding the information provided.

Best regards,

Veraliz Zambrano Luna Paola Morillo

SWA-Application Product Manager Local Safety Officer
CEAC LATAM HUB México

Hosted By: ______________________________________________

Date: ____________________
Signature: ________________

QN-CPS-2018-113 V2 Latam CEAC Hub México- SWA Application.Ver.1