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.
Reported: April 24, 2019 Initiated: March 15, 2019 #Z-1137-2019
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.
Details
- Recalling Firm
- bioMerieux, Inc.
- Units Affected
- 10784 cartons
- Distribution
- Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by bioMerieux, Inc.. Units affected: 10784 cartons.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1137-2019.
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