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 the rubric defines as unlikely to cause adverse health consequences. The issue is a documentation error regarding performance limitations, fitting the 'documentation issues' criterion for a Low severity score.
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 Staphylo
- 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.
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