medical Class II Updated 2019-04-24

bioMerieux, Inc. recalls Biomerieux Vitek 2 Test kit VITEK 2 is an automated syst

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

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

Lot/Code Info: 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)

View official government recall

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