Z-1137-2019 Class II Terminated
FDA device recall Z-1137-2019 was initiated by bioMerieux, Inc. on March 15, 2019 and is designated Class II. 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… The recall status is terminated (terminated August 17, 2021). Affected quantity: 10784 cartons.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- March 15, 2019
- Termination Date
- August 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10784 cartons
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.
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.
Distribution Pattern
Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
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)