Number: 3573

Title: VIDAS® B.R.A.H.M.S PCT - Reference 30450 - New Claim Launch

This MAR applies to: CLINICAL ONLY

Catalog Profile: BD/BD3

Reference N°/ “System-Product-Service” Name : 30450
Lot/Serial: N/A
Expiry date: NA
Required Actions: See section B – Deadline: 28-AUG-2017

Issue Date : 28-JUL-2017

Section A: Details

Dear colleagues,
We would like to inform you about the following:

1. Product Distribution

Material 30450

Sold-to Country
pt Sold to Party Name Country name code
Subsidiaries AR01 BIOMERIEUX ARGENTINA Argentina AR
AT01 BIOMERIEUX AUSTRIA GMBH Austria AT
AU01 BIOMERIEUX AUSTRALIA P/L Australia AU NZ
BR01 BIOMERIEUX BRASIL INDUSTRIA E Brazil BR
CA01 BIOMERIEUX CANADA, INC. Canada CA
CH01 BIOMERIEUX SUISSE S.A. Switzerland CH
CL01 BIOMERIEUX CHILE S.A. Chile CL
CO01 BIOMERIEUX COLOMBIA S.A.S Colombia CO
CZ01 BIOMERIEUX CZ S.R.O. Czech Republic CZ SK
DE01 BIOMERIEUX DEUTSCHLAND GMBH Germany DE
DZ01 BIOMERIEUX ALGERIE Algeria DZ
ES01 BIOMERIEUX ESPAÑA, S.A. Spain ES GI
FR01 BIOMERIEUX S.A France FR
GB01 BIOMERIEUX UK LTD United Kingdom GB IE

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 GR01 BIOMERIEUX HELLAS S.A. Greece GR
HK01 BIOMERIEUX CHINA LIMITED Hong Kong HK TW
HU01 BIOMERIEUX HUNGARIA KFT. Hungary HU
IN01 BIOMERIEUX INDIA PVT. LTD India IN
IT01 BIOMERIEUX ITALIA S.P.A. Italy IT
JP01 SYSMEX BIOMERIEUX CO., LTD Japan JP
KR01 BIOMERIEUX KOREA CO., LTD South Korea KR
MX01 BIOMERIEUX MEXICO SA DE CV Mexico MX
NL01 BIOMERIEUX BENELUX BV Netherlands NL BE / LU
PL01 bioMerieux Polska Sp. z o.o. Poland PL
PT01 BIOMERIEUX PORTUGAL, LDA Portugal PT
RU02 BIOMERIEUX RUSS LLC, Russian Fed. RU
DK /FI /
SE01 BIOMERIEUX SWEDEN AB Sweden SE NO
SG01 BIOMERIEUX SINGAPORE PTE LTD Singapore SG
TH01 BIOMERIEUX THAILAND LTD Thailand TH
TR01 BIOMERIEUX DIAGNOSTIK A.S. Turkey TR
US01 BIOMERIEUX US United States US
ZA01 BIOMERIEUX SOUTH AFRICA PTY South Africa ZA NA
Distributors 1029326 PT. ENSEVAL MEDIKA PRIMA Indonesia ID
1029918 QUIMICA SUIZA SA Peru PE
1030057 AL JEEL MEDICAL Saudi Arabia SA
1030189 MEDILAB Gabon GA
1030286 TOO SPF MEDILAND Kazakhstan KZ
1030583 TNC EVERLIGHT PHILIPPINES, INC. Philippines PH
1030624 BIOSYNERGIE Ivory Coast CI
1030694 OKKAR THIRI COMPANY LIMITED Myanmar MM
1030908 HASS SCIENTIFIC Kenya KE
1030995 YUNYCOM DOO Serbia RS
1031022 MAGHREB MEDICAL MAINTENANCE Tunisia TN
1031183 BIOTEK LTD Macedonia MK
1031376 BIOTECK S.A.L Lebanon LB
Romania (including
1031779 S.C. MEDICLIM S.R.L. Moldavia) RO
1032146 BGL SYSMET Sarl Benin BJ
1032570 TUZLA FARM Bosnia-Herz. BA
1032696 AL HASHAR PHARMACY Oman OM
1032990 SETEMA LIMITED PLC. Ethiopia ET
1033969 TRESUL S.A. Uruguay UY
1097357 PYRAMIDPHARMA Tanzania TZ
1034643 ANALYTICAL INSTRUMENTS (PVT) LTD Sri Lanka LK
1034755 AL HAYAT PHARMACEUTICALS Utd.Arab Emir. AE
1034890 UAB DIAMEDICA Lithuania LT
1035066 BIOFASO SARL Burkina Faso BF
1035226 MIKRO + POLO d.o.o. Slovenia SI
ALI ALSUWAIDI TRADING
1035279 ESTABLISHMENT Qatar QA
1035324 BADER SULTAN & BROS CO WLL Kuwait KW
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 1035388 TECNO DIAGNOSTICA S.A. Costa Rica CR
1035801 TECNOFAST S.A Paraguay PY
1035835 SUED & FARGESA S. R. L. Dominican Rep. DO
1035919 A & B d.o.o. Croatia HR
1035981 INVERSIONES SAGRAV S.A. Panama PA
Congo / Dem. Rep.
1036110 WAGENIA SARL Congo CG
1036446 DIAMEDICA OÜ Estonia EE
1036944 SIA DIAMEDICA Latvia LV
1037064 PERINO Mozambique MZ
1037241 INTER BUSINESS 91 LTD Bulgaria BG
1037316 FARMINPEX N.V. Dutch Antilles AN
1037462 SAHA DIAGNOSTICS Djibouti DJ
1037710 TECNO DIAGNOSTICA NICARAGUA SA Nicaragua NI
1038017 ILEX MEDICAL LTD Israel IL
1038018 MR ABDALLAH SAADE Syria SY
1038050 PRIMAMEDI LTD Georgia GE
1038371 SLEM MEDICAL Chad TD
1038470 ULTRA DIAGNOSTIC Egypt EG
1038737 ISMAILCO MEDICAL COMPANY Jordan JO
1038802 GULF PHARMACY AND GENERAL STORE Bahrain BH
1038835 PERINO LDA Angola AO
1039252 BROMA BEL D.O.O. Bosnia-Herz. BA
1039487 ISED N.V. Dutch Antilles AN
1039792 ISMAILIYA TRADING AGENCIES & Iraq IQ
1039948 PISHRO TASHKHIS FARDAVAR Iran IR
Pakistan (including
1038615 GMS GLOBAL MARKETING SERVICES Afghanistan) PK
1042795 I.M. ALLIANCE SARL Morocco MA
1042815 KOTHAR MEDICAL Mauretania MR
1043421 FAS DIAGNOSTIC GROUP, INC. Philippines PH
1054476 MEDIGENE SDN BHD Malaysia MY
1055815 SSM - SYSTEMES MEDICAUX Senegal SN
DIA VERITAS Ltd. ***CLOS*** / IMD (UK)
1035551 / Ukrbio (Ukraine) Ukraine UA
1063040 ORGANIZACOES MAURO RUI, LDA Angola AO
1071059 TECHNOWORTH ASSOCIATES LTD Bangladesh BD
1071118 BioMali et Services-sa Mali ML
1075774 LABORATORIOS LA PAZ LTDA Bolivia BO
1076188 LABYMED S.A. Guatemala GT
1030805 GANBARO C.A. Venezuela VE
1089884 SIMED S.A. Ecuador EC
1090591 Lablink Laboratory Services Co. Ltd Sudan SD
SLT LTD. / BIOMEDEX sro / BIOMEDICAL
EXPORT sro / VITECO PRIVATE MEDICAL
1091979 UNITARY Belarus BY
1092723 LIFETRONIK LLC Mongolia MN
1097670 LAVITEC TECHNOLOGY., JSC Vietnam VN

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 1100291 SIMED PERU SAC Peru PE
1100455 Gulf Integrated Security Solutions ( GISS ) Kuwait KW
Direct LRAM DE LA FRATERNELLE
customers 1030984 GENDARMERIE Morocco MA
LABO.D'ANALYSES MEDICALES DU
1037517 CENTRE Burkina Faso BF
1037533 TEDIS SA Congo CG
1038037 TEDIS SA Nigeria NG
1049476 PERINO Equatorial Guinea GQ
1055441 TYM MEDICAL Ivory Coast CI
1094171 ICOR Instituto do Coração Mozambique MZ
1070579 VIMEDIMEX BINH DUONG Vietnam VN
1040683 Compte générique export*

* RANDOX LABORATORIES
44 LARGY ROAD
CRUMLIN - BT294RB
UK

* IRD Institut de recherche

08 B.P. 841
COTONOU
BENIN

2. Product Description

VIDAS® B·R·A·H·M·S PCT™ is an automated test for use on the VIDAS® family of instruments for the
determination of human procalcitonin in human serum or plasma (lithium heparin) using the ELFA (Enzyme-
Linked Fluorescent Assay) technique.
Used in conjunction with other laboratory findings and clinical assessments, VIDAS® B•R•A•H•M•S PCT™ aids
in the risk assessment of critically ill patients on their first day of ICU admission, for progression to severe
sepsis and septic shock.
Used in conjunction with other laboratory findings and clinical assessments, VIDAS® B·R·A·H·M·S PCT™ also
aids in decision making on antibiotic therapy for patients with lower respiratory tract infections (LRTI)
(including community acquired pneumonia, exacerbation of chronic obstructive pulmonary disease, acute
bronchitis) seen during medical consultations, including at the Emergency Department.

3. Context

We would like to inform you that a new package insert has been implemented for VIDAS® B.R.A.H.M.S PCT™
reference 30450.

In order to support this launch, please find here below additional material:
• New claim
• Package insert’s changes
• New version and first batch
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 1. New claim

• The reagent has not been modified : same content, same labelling and same reference as previously
• The new claim has been added in the section “INDICATION FOR USE”.

The package insert has changed according to a Scientific review process validating the use of PCT in LRTI.
The review named proREAL* was conducted in 4 steps :

• Identification of relevant peer reviewed publications with PCT guiding antibiotic treatment
• Assessment of the relevance of the published data regarding study objectives
• Analysis of data in the selected publications
• Creating a summary of the data and conclusions whether PCT is safe and effective to reduce antibiotic
treatments in patients with LRTI

* proREAL : effectiveness and Safety of Procalcitonin-Guided Antibiotic Therapy in Lower Respiratory Tract Infections in Real
Life.

2. Package insert’s changes

In addition to the information related to the LRTI claim, some other changes have been implemented in different
parts of the package insert.

• Section RANGE OF EXPECTED VALUES is enhanced with information related to starting and discontinue an
antibiotic therapy.

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• Section PERFORMANCE :
o The table related to the precision studies includes new samples especially with low level
concentrations.
o The table related to potentially interfering substances includes additional tested drugs.
o The clinical performance part includes data related to LRTI claim.

3. New version and first batch.

• The version (13207 H) of VIDAS® B.R.A.H.M.S. PCT™ package insert has been implemented from the lot
1005713920 (expiry date 26-APR-2018).
• This batch of VIDAS® B.R.A.H.M.S. PCT™ reference 30450 was released on May the 23rd, 2017.
• As the VIDAS® B.R.A.H.M.S PCT™ reagent remains the same, there is no need to scan the PTC barcode if this
assay has been already used.

3. Customer letter
You will find attached a customer letter
This Corporate document in English has to be sent to every customer who orders VIDAS® B.R.A.H.M.S PCT™
reference 30450.
You can join a translation in your local language for better understanding (please respect the wording and do
not change the meaning).
Customers will then have to acknowledge reception by filling the form enclosed.

Please click on the paper clip icon

If you have any additional question or doubt concerning this MAR in general, please do not hesitate to contact
the GCS through general email box :

gcs_immunomarcy@biomerieux.com

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 Section B: Required actions
According the table below:
1. Please immediately acknowledge receipt (AR) of this MAR.
2. Translate and Send the Customer Letter
3. Fill the acknowledgement of completion (AC) for this MAR by 28-AUG-2017

Subsidiaries using SAP
Subsidiaries not using SAP
Distributors
1) Acknowledgement of Receipt : Please immediately acknowledge receipt (AR) of this
MAR within SAP.
2) Acknowledgement of Completion :please also manage the acknowledgement of
completion within SAP.
1) Acknowledgement of Receipt : Please immediately upload the Acknowledgement of
Receipt in LiveLink after signing and completing sections #1 and #2 of the
Acknowledgement Form.
2) Acknowledgement of Completion : After completing and signing Section #3 before
the deadline, please upload the Acknowledgement of Completion in Livelink
1) Acknowledgement of Receipt : Please immediately Acknowledge of Receipt of this
MAR by completing sections #1 and #2 of the Acknowledgement Form and sending
it by email to fieldactions@biomerieux.com or by fax to +33 4 78 87 21 79.
2) Acknowledgement of Completion : After completing and signing Section #3 before
the deadline, please send it by email to fieldactions@biomerieux.com or by fax to
+33 4 78 87 21 79.

Section C: Contact Information

+ 1 919 620 33 99 + 33 4 78 87 20 80 gcs_immunomarcy@biomerieux.com gcs.biomerieux.fr

℡ @ www

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 Section D: Acknowledgement Form

Number: 3573 Title: MAR - VIDAS B.R.A.H.M.S PCT – Deadline: 28-AUG-2017

Reference 30450 - New Claim Launch

SECTION 1
Location
Group Company or Distributor Name(s) Country Account #
A
B
C
D
--------------------------------------------------------------------------------
SECTION 2
Acknowledgement of Receipt (AR)
Print Name
Sign Name
Position
Date (dd/MMM/yyyy)

--------------------------------------------------------------------------------
SECTION 3

Field Action Not Applicable

Field Action Applicable (Fill the “Acknowledgment of Completion” table below)

Acknowledgement of Completion (AC)
Group Company 1. REF # 2. LOT # 3. Total 4. Total 5. Total 6. Total 7. Total 9. Total
or Distributor Received Shipped On Hand Destroyed Instruments Updates
Affected Completed
A N.A. N.A. N.A. N.A. N.A. N.A. N.A. N.A.

Customer Letter Issue date:

Print Name
Sign Name
Position
Date (dd/MMM/yyyy)

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