Customer Service Industry BIOMÉRIEUX

Industrial Microbiology

Number : 4143 Title : VIDAS® Industry Software Release – Version 4.10 with Windows 10
Catalog Profile: BQ /C09
Reference N°/ “System-Product-Service” Name : VIDAS® - Ref 99735, 421002, 410417
Lot/Serial: N/A
Expiry date: N/A
Required Actions: See section B – Deadline: 30-JUN-2020

Issue Date : February 18, 2019

Section A: Details

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

Following the GCS info 3866 informing the end of support of Windows 7 and Windows XP obsolescence by
Microsoft, we have to migrate our Operating Systems to Windows 10 including the VIDAS® Industry Software
to version 4.10:
 VIDAS® 4.10 Windows 10 version is dedicated only for Industry customers
 VIDAS® 4.10 Windows 10 version is supported on RP5800 and RP5810 computers

This MAR 4143 cancels and replaces the MAR 3801.

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 1 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 1. Product Distribution

SAP Code SAP Name Country

Subsidiaries AR01 BIOMERIEUX ARGENTINA Argentina
AT01 BIOMERIEUX AUSTRIA GMBH Austria
AU01 BIOMERIEUX AUSTRALIA P/L Australia
BE01 BIOMERIEUX BENELUX Belgium
BR01 BIOMERIEUX BRASIL INDUSTRIA E Brazil
CA01 BIOMERIEUX CANADA, INC. Canada
CH01 BIOMERIEUX SUISSE S.A. Switzerland
CL01 BIOMERIEUX CHILE S.A. Chile
CO01 BIOMERIEUX COLOMBIA S.A.S Colombia
CZ01 BIOMERIEUX CZ S.R.O. Czech Republic
DE01 BIOMERIEUX DEUTSCHLAND GMBH Germany
ES01 BIOMERIEUX ESPAÑA, S.A. Spain
FR01 BIOMERIEUX S.A France
GB01 BIOMERIEUX UK LTD United Kingdom
GR01 BIOMERIEUX HELLAS S.A. Greece
HK01 BIOMERIEUX CHINA LIMITED Hong Kong
HU01 BIOMERIEUX HUNGARIA KFT. Hungary
IN01 BIOMERIEUX INDIA PVT. LTD India
IT01 BIOMERIEUX ITALIA S.P.A. Italy
JP01 bioMerieux Japan LTD Japan
KR01 BIOMERIEUX KOREA CO., LTD South Korea
MX01 BIOMERIEUX MEXICO SA DE CV Mexico
NL01 BIOMERIEUX BENELUX BV Netherlands
PL01 bioMerieux Polska Sp. z o.o. Poland
PT01 BIOMERIEUX PORTUGAL, LDA Portugal
RS01 BIOMERIEUX SRB DOO Serbia
RU02 BIOMERIEUX RUSS LLC, Russian Fed.
SE01 BIOMERIEUX SWEDEN AB Sweden
SG01 BIOMERIEUX SINGAPORE PTE LTD Singapore
TH01 BIOMERIEUX THAILAND LTD Thailand
TR01 BIOMERIEUX DIAGNOSTIK A.S. Turkey
US01 BIOMERIEUX US United States
ZA01 BIOMERIEUX SOUTH AFRICA PTY South Africa
Distributors 1026091 LABTRONIC Guatemala
1029326 PT. ENSEVAL MEDIKA PRIMA Indonesia
1029918 QUIMICA SUIZA SA Peru
1030057 AL JEEL MEDICAL TRADING COMPANY Saudi Arabia
1030189 MEDILAB Gabon
1030286 TOO SPF MEDILAND Kazakhstan
1030583 TNC EVERLIGHT PHILIPPINES, INC. Philippines
1030694 OKKAR THIRI COMPANY LIMITED Myanmar

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 2 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 1030805 GANBARO C.A. Venezuela
1030908 HASS SCIENTIFIC Kenya
1030994 FUAD ABDUL JALIL AL FADHLI & SONS Saudi Arabia
1030995 YUNYCOM DOO Serbia
1031022 MAGHREB MEDICAL MAINTENANCE Tunisia
1031035 BIO-PLUS Niger
1031183 BIOTEK LTD Macedonia
1031376 BIOTECK S.A.L Lebanon
1031779 S.C. MEDICLIM S.R.L. Romania
1032146 BGL SYSMET Sarl Benin
1032570 TUZLA FARM Bosnia-Herz.
1032696 AL HASHAR PHARMACY Oman
1032990 SETEMA LIMITED PLC Ethiopia
1033969 TRESUL S.A. Uruguay
1034643 ANALYTICAL INSTRUMENTS (PVT) LTD Sri Lanka
1034755 AL HAYAT PHARMACEUTICALS Utd.Arab Emir.
1034890 UAB DIAMEDICA Lithuania
1034910 MEDICALEX SARL Cameroon
1035066 BIOFASO SARL Burkina Faso
1035226 MIKRO + POLO d.o.o. Slovenia
1035279 ALI ALSUWAIDI TRADING ESTABLISHMENT Qatar
1035388 TECNO DIAGNOSTICA S.A. Costa Rica
1063022 INTERNATIONAL MEDICAL DEVICE / UKRBIO Ukraine
1035801 TECNOFAST S.A Paraguay
1035835 SUED & FARGESA S. R. L. Dominican Rep.
1035919 A & B d.o.o. Croatia
1035981 INVERSIONES SAGRAV S.A. Panama
1035989 MED-SOLUTIONS CORP Yemen
1036110 WAGENIA SARL Dem. Rep. Congo
1036359 DIAR ASSLAM COMPANY Libya
1036446 DIAMEDICA OÜ Estonia
1036944 SIA DIAMEDICA Latvia
1037064 PERINO Mozambique
1037215 EUROP CONTINENTS Cambodia
1037237 PERINO Cape Verde
1037316 FARMINPEX N.V. Dutch Antilles
1037462 SAHA DIAGNOSTIC Djibouti
1037710 TECNO DIAGNOSTICA NICARAGUA SA Nicaragua
1038017 ILEX MEDICAL LTD Israel
1038018 MR ABDALLAH SAADE Syria
1038050 PRIMAMEDI LTD Georgia
1038067 AL-WALID MEDICAL TRADING CO.LTD Palestine
1038371 SLEM MEDICAL Chad
1038425 CONCERN-ENERGOMASH CJSC Armenia
1038470 ULTRA DIAGNOSTIC Egypt

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 3 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 1038615 GMS GLOBAL MARKETING SERVICES Pakistan
1038728 CHERUBINO LTD Malta
1038737 ISMAILCO MEDICAL COMPANY Jordan
1038802 GULF PHARMACY AND GENERAL STORE Bahrain
1038835 PERINO LDA Angola
1039100 LABONET Guinea
1039252 BROMA BEL D.O.O. Bosnia-Herz.
1039305 TECNO DIAGNOSTICA DE EL SALVADOR, El Salvador
1039376 INDUSTRIES MEDICO-CHIRURGICALES Algeria
1039487 ISED N.V. Dutch Antilles
1039792 ISMAILIYA TRADING AGENCIES & Iraq
1039948 PISHRO TASHKHIS FARDAVAR Iran
1040354 SHISAS TRADING CONCERN PVT LTD Nepal
1040766 FLOW CYTOMETRY CENTRE Zimbabwe
1042795 I.M. ALLIANCE SARL Morocco
1042815 KOTHAR MEDICAL Mauretania
1043099 ISLA LAB CARIBBEAN LLC Anguilla
1043329 BGL SYSMET Sarl Togo
1043421 FAS DIAGNOSTIC GROUP, INC. Philippines
1049008 OZEL NESIL Azerbaijan
1054442 DIAGNOSTIC SYSTEMS (M) SDN BHD Malaysia
1054476 MEDIGENE SDN BHD Malaysia
1054863 SEDA HJ Turkmenistan
1054907 MEDPHARM Guam
1054909 MC QUIPP TECHNISELL Brunei Daruss.
1055441 TYM MEDICAL Cote d'Ivoire
1055815 SSM - SYSTEMES MEDICAUX Senegal
1063040 ORGANIZACOES MAURO RUI, LDA Angola
1070840 DKSH TECHNOLOGY CO LTD Vietnam
1071059 TECHNOWORTH ASSOCIATES LTD Bangladesh
DKSH VIETNAM CO., LTD./VIMEDIMEX BINH
1071113 Vietnam
DUONG
1071118 BioMali et Services-sa Mali
1075774 LABORATORIOS LA PAZ LTDA Bolivia
1076188 LABYMED S.A. Guatemala
1076286 NAMARKA MODERN MEDICALS LTD Ghana
1082825 RAINPHIL INC Philippines
1083268 MILLITEST DOO (I) Serbia
1085804 PT. DIPA PUSPA LABSAINS Indonesia
1089884 SIMED S.A. (CL) Ecuador
1090591 Lablink Laboratory Services Co. Ltd Sudan
1108678 SLT LTD /VIRALAX S.R.O. Belarus
1092723 LIFETRONIK LLC Mongolia
1095484 Union Diagnostics & Clinical Servic Nigeria
1095680 OSIYOMEDIKA LTD Uzbekistan

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 4 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 1097357 PYRAMID PHARMA LIMITED Tanzania
1097670 LAVITEC TECHNOLOGY JSC Vietnam
1100291 SIMED PERU S.A.C. Peru
1100455 Gulf Integrated Security Solutions Kuwait
1103797 PRODYLAB, PRODUCTOS DE DIAGNOSTICO Honduras
1103997 DCL LABORATORY PRODUCTS LTD Nigeria
1107336 MEDICLIM EOOD Bulgaria

2. Product Description
 Windows 10
Windows 10 brings more Cybersecurity which answers to our customer’s requirements.
 BitLocker
BitLocker is an encryption method embedded in Windows 10 operating systems.
The VIDAS® computer implements full disk encryption on the internal storage to prevent the disclosure of
sensitive data through offline attacks.

 Windows Session accounts evolution:

o Customer accounts:
 No laboratory Technician and Laboratory Super User accounts are available anymore by
default.
 The password of the LabAdmin Windows account will have to be modified at the first
connection.
o FSE accounts:
 bmx_remote account is not available anymore
 bmx_admin and Db2bmx accounts are still available with same use as previously
 Windows Session Locked
Due to new security management, Windows will be automatically locked after 30 minutes of inactivity. It
will be requested to enter again login and password in order to log on Windows.
This 30min locked out time can be changed. Please refer to Update procedures.

Note : bioMerieux recommends to not exceed 2 hours as inactivity time lockout . If more, it’s the
customer’s responsibility.

 Full system backup

It is mandatory to use the FBRT 5.4 in order to perform the Full System Backup/Restore on Windows 10.
The Full Backup Restore Tool (FBRT) 5.4 is included on each VIDAS® 4.10 Master DVD ½. The FBRT 5.4 can
also be used via a specific USB key (Ref 498000).
 BIOS configuration:
o On computer RP5810, a BIOS password is configured since Windows 7, in order to avoid
parameters access (like the startup order) to unauthorized user. System can’t start on an external
drive or CD/DVD.
o The same BIOS password is added on computer RP5800 when updating it into Windows 10.
 VILINK agent installer:
o In case of VILINK configuration, the VILINK agent installer 3.2.0 is already installed in the VIDAS®
4.10 Master DVDs.
Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 5 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
  VIDAS Software update
 VIDAS kit expiry date management : bug 2024 correction
The VIDAS kit expiry date is encoded into the barcode strip.
Today , the VIDAS software is able to correctly read the expiry dates until December 31st of 2024.
A strip whose expiry date is January 1st of 2025 will be interpreted as expired by VIDAS Software (date
decoded =1989).
The new software version will allow the VIDAS Software to interpret correctly the expiry date after 2024.
As our reagent kits can have up to 18 months of expiratory date, as a consequence by mid-2022 any
software version besides V4.10 will give an error of reagent kit expired.
 VIDAS Run Control functionality / Already available in the software version 4.8.2
VIDAS Software version 4.10 = VIDAS Software version 4.8.2 .The versioning, 4.8.2 to 4.10, is due to the
new Operating System Windows 10.
VIDAS® Run Control is a control embedded with the assay protocol which allows the VIDAS® analyzer to
detect pipetting dysfunctions (leakage or clogging) impacting the biological result of a VIDAS® assay.
VIDAS® Run Control corresponds to a pipetting sequence occurring at the end of the biological protocol.
It uses the reagent strips and SPR® already in place.

This new features is transparent for the user.

VIDAS® Run Control allows to ensure an improved security result quality.
 This version also updates the knowledge base / Already available in the software version 4.8.2:
- Industry assays with an up-to-date list.
- VIDAS Run Control assays for Industry assays only.
The Clinical assays knowledge base remains the same : with a list of clinical assays form VU04 = Software
version 4.70/4.7.1.
Maintenance protocols (including Leak Test)remain the same.
 Label Industry
The label of VIDAS application has been customized in order to be more in alignment with industry use.
Before : example of complete demographic header

With Software version 4.10 we have

Note: if the customer wants to come back to clinical label, please refer to the update procedure.

 New Graphic chart

You will find below some screenshots of the new graphic chart.

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 6 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 The other screens remain unchanged .

 VIDAS Firmware update:

 With VIDAS® 4.10 version, the firmware version must be:
o 6.04 on NSH instrument or
o 5.03 on VSH instrument (EEPROM)

 This firmware update has already been done with the VIDAS® 4.8.2version

 Extra Putty needed to update firmware on NSH instrument is installed and configured by default on all
VIDAS® 4.10 Master DVDs

3. Context
Reminder about End of support and Obsolescence :
o You can migrate the customer data from all VIDAS® Industry Platforms (DC7700, DC7800 and RP5700) in
Windows XP and software version 4.7.1, to the latest software version 4.10. This migration will have to be
done with the replacement of the computer (RP5810 in Windows 10).
o The VIDAS® Industry Platforms (RP5800 and RP5810) in Windows 7 and software versions 4.7.1,or 4.8.2,
can be migrated to Windows 10 and software version 4.10, without replacing the computer.

The targeted perimeter of the 4.10:

Industry customer
(Food and Veterinary)
This software version R4.10 / Windows 10 can be implemented on:
o VIDAS Blue equipped with Old Scanner Head (OSH, also called VSH) or New Scanner Head (NSH)
o No update for VIDAS Grey Reminder MAR 4116 and MAR 4123

o Platforms RP5800 and RP5810

*Caution : Any other platform (DC7700, DC7800 and RP5700) needs to be replaced by a RP5810;
Subsidiaries : this replacement has to be anticipated in your budget.

BCI Link software version is not changed and no additional information is added to the protocol due to the VRC,
this feature is not transmitted to the LIMS and neither the possibility to send any information if desired.

VIDAS® Version 4.10 is a non IVD product.

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 7 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 4. Customer Letter

Letter to be sent at the time of the VIDAS update/VIDAS installation

Please click on the paper clip icon

5. Additional information

 Reminder : SAP code linked to VIDAS Run Control

Catalogue Software Error Designation

profil Field* code

C09 VIDAS® CA12 VIDAS RUN CONTROL FAILURE

V4.10 Example : VIDAS Run Control failure without instrument root
cause identified.
B305 VRC ERROR DUE TO UNSTUCK DOT
Example : Absence or non-correctly stuck color-dot on the
VIDAS SPR’s, observed following an error of the VIDAS RUN
CONTROL

Please do not mixed up the error code B226 (unstuck dot)

with B305 dedicated for ERRVRC generated by unstuck dot
BQ NA B306 VRC ERROR DUE TO HOLE ABSENCE ON DOT
Example: Hole absence on the dot observed following an
error of the VIDAS RUN CONTROL
B308 VRC ERROR DUE TO COAGULANT SAMPLE
Example: VRC error occurred because of the presence of
particles /solid matter in the sample well or in the SPR
B353 VRC ERROR PUNCTUAL ALARM
VIDAS Run Control failure without reagent or sample root
cause identified
*After any intervention, the local support must tick the option in SAP software field, the software version
option “VIDAS® 4.10”.
Important :

For all VIDAS system configuration updated in 4.10 the local SAP administrator must assign the “VIDAS®
INDUSTRY UPDATE KIT V4.10.” Ref: 423349 to the customer configuration.

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 8 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
  Support organization

CSI Marcy GCS Immunology

For any contact regarding Reagents and For any contact regarding Instrument
Application please contact CSI please contact GCS Immuno

Select catalogue profile BQ Select catalogue profile C09

+33 4 78 87 77 51 +33 6 50 69 75 43

csi@biomerieux.com gcs_immunomarcy@biomerieux.com
or
Key word : AS Food / VIDAS Run Control GCS Portal
https://gcs.biomerieux.fr/index.php

 Documentation
1. Customer documentation

1.1 - Addendum to the User’s manual (ref 161150-723- C) available in the following languages :
• Chinese (Simplified) • Czech • Danish • English • Estonian • Finish • French • German • Greek •
Hungarian • Italian • Latvian • Lithuanian • Norwegian • Polish • Portuguese • Slovak • Spanish •
Swedish • Turkish
- In DVD (“VIDAS® Industry V4.8. Documentation***” ) available in the VIDAS® INDUSTRY UPDATE
KIT V 4.10 Ref : 423349 and on the Technical Library
***The VIDAS® Industry V4.8. Documentation is applicable for VIDAS® software version 4.10

1.2 VIDAS® Run Control Error Troubleshooting Guide in laminated format available in the VIDAS®
INDUSTRY UPDATE KIT V4.10 (ref 423349) .
2. Documentation for AS / SE Support Desk and FSE / FAS. Internal Use ONLY

Document Name Where in GCS Portal Link

4143 - VRC presentation - VIDAS Industry Software Release -
Version 4.10 with Windows 10 - Att.1 GCS Portal
4143 - VRC movie 1 - VIDAS Industry Software Release - Version
4.10 with Windows 10 - Att.2
GCS Portal
4143 - VRC movie 2 - VIDAS Industry -Software Release - Version
4.10 with Windows 10 - Att.3 GCS Portal
Troubleshooting - VIDAS Industry Software Release - Version 4.10
with Windows 10 - for FAS - MAR 4143 GCS Portal
Troubleshooting - VIDAS - Industry Software Release - Version
4.10 with Win10 - for FSE - MAR 4143***
*** This document is applicable for software version 4.10 GCS Portal
even if you can read version 4.8 in some pages.

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 9 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 FAQ - VIDAS - VIDAS Run Control - MAR 4143 available on GCS
Portal GCS Portal
4143 - VIDAS - Certificate for Software Evolution 4.10 - Att.4 to
give to the customers if needed GCS Portal
4143 - Certificate for Firmware - VIDAS Industry Software Release
- Version 4.10 with Win10 - Att.5 GCS Portal
“Qualification Protocol for the VIDAS® system with VIDAS Run®
Available on the Technical Library
Control feature” - 161150 -1087-C –VIDAS MAR 4143
In the different documentations, the screen-print and VIDAS results copy are for example .You may read a
software version different than 4.10 . In the footer you may read the update kit version 4.8.or 4.8.2 .
All are applicable for 4.10.
3. Material and Documentation for FSE. Internal Use ONLY

SOFTWARE & PRODUCT

For What?

GCS Portal Link

INSTALLATION
UPDATE P570

UPDATE P580

UPDATE P581
Product Name Ref. Where

0
VIDAS® RP 5800 MASTER DVD V4.10 INDUSTRY 423256 Available to order X
VIDAS® RP 5810 MASTER DVD V4.10 INDUSTRY 423258 Available to order X X X
VIDAS® RP 5810 MASTER DVD SW V4.7.1 421408 Available to order X
VIDAS VRC KIT 4.10 including EEprom with FW
5.03 (used only in case of VSH instrument and 423349 Available to order X X** X** X
updating from VIDAS® 4.7.1)
Bitlocker Recovery USB Key 418904 Available to order X X
423156 Available to order
License Windows 10 X X
ARROW VIDAS® Computer HP RP5810 W10 423259 Available to order
X X
INDUSTRY
Software Firmware - VIDAS - New Version of
the Software V4.8. VD0772C-604 - MAR 4143
N.A. X
(used only in case of NSH instrument and New X X X
installation or updating from VIDAS® 4.7.1)

Software Firmware - VIDAS - New Version of

the Software V4.8. Extraputty V0-30 – MAR N.A. X
X X X
4143

** No need of VIDAS VRC KIT 4.10 if updating from VIDAS® 4.8.2 version

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 10 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 UPDATE PROCEDURE
For What?

GCS Portal Link

UPDATE P5700

UPDATE P5800

UPDATE P5810

INSTALLATION
Product Name Ref. Where

Update procedure VIDAS 4.7.1_4.8.2 Windows 7 to VIDAS® 161150-

4.10 Windows 10 RP5810_RP5800 1237 A X X

Update procedure VIDAS 4.7.1 Windows XP to VIDAS® 4.10 161150-

Windows 10 RP5810 1238 A X

161150-
Installation procedure VIDAS 4.10 Windows 10 RP5810
1235 A X

SERVICE MANUAL

Document Name Reference Revision Where Link

Connectivity BCI Service Manual Technical Library &
for LIS 161150-486 B
GCS Portal
Connectivity BCI Service Manual Technical Library &
for FSE 161150-485 E
GCS Portal
Service Manual
4501-2229 2.0
GCS Portal

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 11 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 Update and Installation process :Summary

Additional Information:
Some situations continue to exist with the V4.10., with an impact for the FSE.
- When using the command TRAYREAD, with Hyperterminal, the correct command should be
TRAYREAD A 0, instead of TRAYREAD A. This command is used to perform a full reading of the
section A with OPT calibrator strips inserted.
- The BURNIN command executed in Hyperterminal doesn’t work and there is no workaround. The
firmware versions impacted are 5.03 for VSH and 6.04 for NSH or higher.
 VILINK

We strongly recommend you to push our remote support solution, to be installed during
the VIDAS Software Update 4.10. The following improvements should be used to enforce
and help the customer to approve the installation of VILINK.

 Apply the recommendations from the GCS Info 3521 to setup the system with the diagnostic cable so you can
increase the remote support.
 A new configuration for VIDAS® (Clinical and Industry) for data monitoring, system information and alerts is
coming very soon. We will monitor all instrument errors, provide a dashboard of the asset and give alerts for
QCV failures and VRC errors.
 Update strategy
The VIDAS® 4.10 update will be done by the FSE

 Systematically during the yearly maintenance, in Industry Customers

 Systematically during the installation of a new VIDAS system, in Industry Customers.
 On Industry customer’s request. In this case we strongly recommend to do the PM at the same time

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 12 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 Once the VIDAS update 4.10 update is done, the FSE will have to:

 Inform the customer on the objective of this new VIDAS Run Control functionality: to secure his
biological results with an automatic control on the VIDAS pipetting function.
 Set up the VIDAS Run Control frequency discussed with the customer.
 Explain to the customer the impact of this new functionality on his workflow.
The VIDAS Run Control protocol will add an extra time to the original protocol, between 6 to 10 minutes,
for a full run.
 Indicate to the customer where to find the VIDAS Run Control information
o In the CD Addendum to the User’s manual
o In bioMerieux technical support
If the customer is not available for the FSE, the FSE must disable the VIDAS Run Control functionality.
In this case, to inform the customer on what is this new functionality and to activate it, different options can be
planned depending on your subsidiary organization.
 A FAS visit can be scheduled with the customer. In the attachment 6 you will find document to help you
to train the customer
4143 - VRC summary - VIDAS® Industry Software Release - Version 4.10 with Windows 10 - Att.6
 A phone call with the customer can be scheduled.
All the documents* mentioned in this MAR are available by clicking the below link:
4143 - MAR - VIDAS - VIDAS® Industry Software Release - Version 4.10 with Windows 10
*If you have trouble opening a pdf file, please copy this file to your desktop to open it.

Section B: Required actions

According to the table below:
1. Please immediately acknowledge receipt (AR) of this MAR
2. Identify all countries and customers for which you are responsible that are impacted by this MAR.
3. Define additional actions required.
a. Translate customer letter, send it to impacted customers
b. Please update your VIDAS Blue installed base as described in the Update Strategy paragraph.
c. Please return the following information:
 Total instruments affected
 Total updates completed.
4. Fill the acknowledgement of completion (AC) for this MAR. The due date for completing the required
activities and submitting the AC is 30-JUN-2020

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 13 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 Subsidiaries using SAP 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 (AC) within SAP.
Subsidiaries not using 1) Acknowledgement of Receipt: Please immediately upload the Acknowledgement of
Receipt (AR) in LiveLink after signing and completing sections #1 and #2 of the
SAP
Acknowledgement Form.
2) Acknowledgement of Completion: After completing and signing Section #3 before
the deadline, please upload the Acknowledgement of Completion (AC) in Livelink
Distributors 1) Acknowledgement of Receipt: Please immediately Acknowledge Receipt (AR) 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

Author: Agnes THEVENET Author : Laurence GOUJON Author: Joao GONCALVES

Function: Expert Industry Function: Expert Immuno Function: Expert Immuno
Department: CSI Department :GCS Department: GCS

If you have any additional questions or doubts concerning this MAR in general, please do not hesitate to contact
CSI or GCS through the general email box.

@ csi@iomerieux.com or gcs_immunomarcy@biomerieux.com

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 14 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind
 Section D: Acknowledgement Form

Number: 4143 Title MAR VIDAS® Industry Software Release – Version 4.10 with Deadline: 30-JUN-2020
Windows 10

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
Check the appropriate box and follow the instructions for completion.
 Field Action Not Applicable (Complete the signature box below and return form.)
 Field Action Applicable
1.
Complete the required information in the table below.
a. Enter information only in the columns that are checked in the table below. Do not alter the column headers.
b. Information must be completed for all group companies or distributors indicated in Section 1 of this form.
c. Ensure that the column totals for Total Shipped, Total On Hand, and Total Destroyed equal the total number
received. (Column 4 + Column 5 + Column 6 = Column 3).
Acknowledgement of Completion (AC)
1. REF # 2. LOT # 3. Total 4. Total 5. Total 6. Total 7. Total 8. Total
Group Company or Distributor Received Shipped On Hand Destroyed Instruments Updates
(from Section 1) Affected Completed

       
A NA NA NA NA NA NA
B NA NA NA NA NA NA
C NA NA NA NA NA NA
D NA NA NA NA NA NA

2. Provide the date of issuance of the customer letter in the space below.
a. Customer letters are always required for FCA and FSCA.
b. Customer letters may not be required for MAR. If there is no customer letter mark N/A below.
c. Customer letters are not required for PSS. Mark N/A below.
Customer Letter Issue date:

3. Complete the signature box below and return form.

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

Number: 4143 Title: VIDAS® PC Industry Software Release – Version 4.10 with Windows 10 INTERNAL USE ONLY Page 15 of 15
MAR 004045 - Rev. 06.D - Field Action Notification Communication Form - CSI MAR - en - Editable
-
VIDA
S-
Wind