Biomerieux Vitek 2 Test kit VITEK 2 is an automated recall
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and…
Why was Biomerieux Vitek 2 Test kit VITEK 2 is an automated 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and…
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 10784 cartons
- Distribution
- Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
- Recall date
- April 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)