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Recall Observatory FDA recall evidence

Device product

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.

Z-1137-2019

March 15, 2019

Class II

Product summary

Firm
bioMerieux, Inc.
Event
Event 82501
Status
Terminated
Classification
Class II
Quantity
10784 cartons
Official record key
device-enforcement:Z-1137-2019

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.