bioMerieux, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1137-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Biomerieux Vitek 2 Test kit 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.

Product Classification:

Class II

Date Initiated: March 15, 2019

Date Posted: April 24, 2019

Recall Number: Z-1137-2019

Event ID: 82501

Reason for Recall:

Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.

Status: Terminated

Product Quantity: 10784 cartons

Code Information:

Ref: 413723 (AST-N254), 418674 (AST-N330) and 422024 (AST-N371 Card) with 8.01/9.01 SW Unique Device Identifier: 03573026404550 (AST-N254) / 03573026474836 (AST-N330) / 03573026604363 (AST-N371)

Distribution Pattern:

Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.

Voluntary or Mandated:

Voluntary: Firm initiated