Device product

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

Z-0639-2019

November 13, 2018

Class II

Product summary

Firm: bioMerieux, Inc.
Event: Event 81589
Status: Terminated
Classification: Class II
Quantity: five (5) VITEK¿ 2 Systems Software version 9.01
Official record key: device-enforcement:Z-0639-2019

Official wording

Reason: The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.

Code information: Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260

Distribution pattern: Nationwide distribution to CO, IL, MO, TX.

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

Software Version 9.01 software may display incorrect