Biomerieux Vitek 2 Gram Positive Test Cards Recalled for Labeling Error
Biomerieux 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 15,006 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604). 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 products were distributed in the Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey. The recall covers lots 742343610, 742347220, 742350010, 742352820, 742355710, 742362540, 742364020, 742368210, 742376540, 742383610, and 742389220, with expiration dates ranging from May 11, 2016, to August 10, 2017.
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 Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Users should contact Biomerieux Inc for further instructions on how to proceed with the recalled items.
The recalled product
- Product
- Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 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
- 15,006
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 (11)
- Lots 742343610 exp. 5/11/16
- 742347220 exp. 6/16/16
- 742350010 exp. 7/14/16
- 742352820 exp. 8/11/16
- 742355710 exp. 9/9/16
- 742362540 exp. 11/16/16
- 742364020 exp. 12/1/16
- 742368210 exp. 1/12/16
- 742376540 exp. 4/5/17
- 742383610 exp. 6/15/17
- and 742389220 exp. 8/10/17.
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.
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Similar recalls
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