bioMerieux, Inc.: VITEK¿ 2 Systems Software Version 9.01 Update Kit.

Is my product affected?

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

• UPC 03573026561260

Check against the official notice below — it lists the full affected range.

What happened

bioMerieux, Inc. is recalling VITEK® 2 Systems Software Version 9.01 Update Kit nationwide in Colorado, Illinois, Missouri, and Texas. The software may display incorrect organism identification information and inaccurate Antimicrobial Susceptibility Testing results when the VITEK® 2 FLEXPREP feature is used. Five units of this software version were distributed under product code KIT UPDT VTK2 9.01 EN.

The recall notice does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide distribution to CO, IL, MO, TX. Quantity: five (5) VITEK¿ 2 Systems Software version 9.01 Lot/code info: Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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