Biomerieux Inc: Medical Device Recall in 2023 - (Recall #: Z-0838-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438

Product Classification:

Class II

Date Initiated: November 9, 2022

Date Posted: January 11, 2023

Recall Number: Z-0838-2023

Event ID: 91148

Reason for Recall:

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Status: Ongoing

Product Quantity: 34 units

Code Information:

UDI/DI 03573026399030, Batch Numbers: 6712257403

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated