bioMerieux VITEK 2 Streptococcus Card Recalled for Incorrect Package Insert
Biomerieux Inc is recalling VITEK 2 AST-ST01 Streptococcus Susceptibility Cards because the package insert did not list the correct limitations of use and performance requirements.
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 identifies the issue as a documentation error (incorrect package insert) without reporting any illnesses, injuries, or adverse health consequences. This aligns with the 'Moderate' criteria for minor labeling or documentation issues.
Plain-English summary
Biomerieux Inc is recalling bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Cards, REF 410 028. These cards are used with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. The recall involves 4/20-card cartons with lot number 540274420.
The recall was initiated because the product package did not contain the correct version of the package insert. The incorrect insert failed to list the appropriate limitations of use and performance requirements for the device.
The affected products were distributed only in Hawaii. Users of the device should contact Biomerieux Inc for further instructions regarding the recall and replacement of the affected units.
The recalled product
- Product
- bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
- Manufacturer
- Biomerieux Inc
- Hazard
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)
- lot number: 540274420
Distribution
Distributed in 1 state:
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