Biomerieux Inc: Medical Device Recall in 2023 - (Recall #: Z-0815-2023)

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 MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

Product Classification:

Class II

Date Initiated: November 9, 2022

Date Posted: January 11, 2023

Recall Number: Z-0815-2023

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: 46 units

Code Information:

UDI/DI 03573026362836, Batch Numbers: 1009391190, 1009434380, 1009472100

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated