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
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as unlikely to cause adverse health consequences. The issue is a documentation error in the product insert regarding performance limitations, which fits the criteria for a Low severity score involving documentation issues.
Plain-English summary
Biomerieux Inc is recalling 180 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662). 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 was initiated because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin. The affected lots are 739348620, 739348622, and 739348623, all with an expiration date of 6/30/16.
The product was 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 recall.
The recalled product
- Product
- Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 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 Staphyl
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 180
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 739348620 exp. 6/30/16
- 739348622 exp. 6/30/16
- and 739348623 exp. 6/30/16.
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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