Biomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives
Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.
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, which typically corresponds to a moderate severity score. The hazard involves potential false positive test results rather than direct physical injury or death, and no illnesses or injuries are reported in the source text.
Plain-English summary
Biomerieux Inc is recalling 1,698 cartons (15,940 cards) of VITEK 2 Gram-positive Susceptibility Cards. The recall involves the VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot #8021232403, manufactured on October 11, 2019, and expiring on April 11, 2021.
The recall was initiated because there is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains when using the VITEK 2 AST-P652 test card. The product is intended for use in clinical laboratories to determine the susceptibility of specific bacteria to antimicrobial agents.
The affected products were not distributed within the United States. Foreign distribution locations include the Netherlands, Luxembourg, and Belgium. Clinical laboratories in these regions should stop using the affected lots and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
- 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)
- Expires 11APR2021
Distribution
Distribution scope not specified by the agency.
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