bioMerieux, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1534-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Product Classification:

Class II

Date Initiated: February 5, 2020

Date Posted: April 1, 2020

Recall Number: Z-1534-2020

Event ID: 84993

Reason for Recall:

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

Status: Terminated

Product Quantity: 4,130 kits (82,600 cards)

Code Information:

REF: 422024 Lot Number: 0210932204

Distribution Pattern:

International distribution in the countries of Germany and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated