bioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards
bioMerieux is recalling VITEK 2 Gram Positive Susceptibility Test Cards because they may produce false susceptible results for specific bacteria to Minocycline.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
bioMerieux, Inc. is recalling 337 kits of VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. The recall affects Lot 485368220 with an expiration date of 12-JAN-17. The product is an in vitro test used in clinical laboratories to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents.
The recall was initiated because the test cards may lead to false susceptible results for these specific bacteria when tested against Minocycline. This could potentially impact clinical decision-making regarding antibiotic treatment.
The affected product was distributed worldwide to the China Taiwan region. There was no distribution to the United States, military, or government entities. Users should stop using the affected lots and contact bioMerieux for further instructions.
The recalled product
- Product
- VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial…
- Manufacturer
- Biomerieux Inc
- Category
- Medical Device — Laboratory Test
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/Serial: 485368220 Expiry: 12-JAN-17
Distribution
Distribution scope not specified by the agency.
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