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 5,575 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673). The product is intended for use with VITEK 2 Systems in clinical laboratories to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents.
The recall is due to a labeling error where the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin. The affected lots are 744357740 (exp. 9/29/16), 744383620 (exp. 6/15/17), and 744389320 (exp. 8/11/17).
The 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-P644 REF 418673), 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
- 5,575
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 (3)
- Lots 744357740 exp. 9/29/16
- 744383620 exp. 6/15/17
- and 744389320 exp. 8/11/17.
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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Similar recalls
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