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.
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 by definition unlikely to cause adverse health consequences, and the issue is a documentation/labeling error regarding performance limitations rather than a direct safety hazard like contamination or malfunction.
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 Staphylo
- 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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