bioMerieux, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0639-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

Product Classification:

Class II

Date Initiated: November 13, 2018

Date Posted: December 26, 2018

Recall Number: Z-0639-2019

Event ID: 81589

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.

Status: Terminated

Product Quantity: five (5) VITEK¿ 2 Systems Software version 9.01

Code Information:

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

Distribution Pattern:

Nationwide distribution to CO, IL, MO, TX.

Voluntary or Mandated:

Voluntary: Firm initiated