Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin."
Plain-English summary
Biomerieux Inc is recalling 2,570 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671). The product is intended for use with VITEK 2 Systems in clinical laboratories to determine the susceptibility of Staphylo, Enterococcus spp., and S. agalactiae to antimicrobial agents.
The recall was initiated because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin. This labeling omission may affect the interpretation of test results for this specific antimicrobial agent.
The affected lots are 743357720 (exp. 9/29/16), 743366820 (exp. 12/29/16), 743376510 (exp. 4/5/17), 743380820 (exp. 5/18/17), and 743387820 (exp. 7/27/17). These products were distributed in the Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey. Clinical laboratories should contact Biomerieux Inc for further instructions regarding the return or replacement of these kits.
The recalled product
- Product
- Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 2,570
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 (5)
- Lots 743357720 exp. 9/29/16
- 743366820 exp. 12/29/16
- 743376510 exp. 4/5/17
- 743380820 exp. 5/18/17
- and 743387820 exp. 7/27/17.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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