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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies this as a Class I recall, which per the rubric mandates a score of at least 4 (Severe) due to the potential for serious adverse health consequences.
Plain-English summary
Biomerieux Inc is recalling 7,497 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579). The product is an in vitro test 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 was initiated because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin. This is a Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected lots are 740340920, 740350820, 740356320, 740361110, 740371720, 740386420, and 740388520. The products were distributed in the Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey. Clinical laboratories should stop using the affected test cards and contact Biomerieux Inc for instructions on return or replacement.
The recalled product
- Product
- Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 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 Staphy
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 7,497
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 (7)
- Lots 740340920 exp. 4/14/16
- 740350820 exp. 7/22/16
- 740356320 exp. 9/15/16
- 740361110 exp. 11/2/16
- 740371720 exp. 2/16/17
- 740386420 exp. 7/13/17
- and 740388520 exp. 8/3/17.
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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