bioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals
bioMerieux is recalling 4,130 kits of VITEK 2 AST-N371 cards because compromised top seals may allow moisture to enter, potentially affecting antibiotic performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential impact on antibiotic performance due to moisture, which fits the criteria for a moderate severity recall involving a theoretical or low-risk contamination/defect without reported harm.
Plain-English summary
bioMerieux, Inc. is recalling 4,130 kits (82,600 cards) of VITEK 2 card AST-N371. The VITEK 2 is an automated system used for the identification and antimicrobial susceptibility testing of bacteria and yeast. The specific lot number is 0210932204, and the reference number is 422024.
The recall was initiated because the top seal of some of the pouches was compromised. This defect can allow moisture to enter the packaging, which may impact some antibiotics on the card. The affected products were distributed internationally in Germany and the Netherlands.
This is a Class II recall. No illnesses or injuries have been reported in connection with this recall. Users should stop using the affected cards and contact bioMerieux, Inc. for further instructions or replacement.
The recalled product
- Product
- VITEK 2 card AST-N371 - Product Usage: The 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. The VITEK 2 utilizes growth-based biochemical patterns…
- Manufacturer
- bioMerieux, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF: 422024 Lot Number: 0210932204
Distribution
Distribution scope not specified by the agency.
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