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.
Check against the official notice below — it lists the full affected range.
bioMerieux, Inc. is recalling certain VITEK 2 test kits used to identify bacteria and test their resistance to antibiotics. The recalled kits—specifically the AST-N254, AST-N330, and AST-N371 models—were found to incorrectly identify some Escherichia coli strains as having an ESBL (Extended Spectrum Beta Lactamase) phenotype when they did not actually have this trait. A total of 10,784 cartons of these kits were distributed internationally to the United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
The affected test kits can be identified by their reference numbers 413723 (AST-N254), 418674 (AST-N330), and 422024 (AST-N371), which were used with software versions 8.01 and 9.01. The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland. Quantity: 10784 cartons 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.