Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards Recalled for Labeling Error
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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, but the source text describes a minor labeling error regarding performance limitations without reporting any illnesses, injuries, or deaths. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically scored as Moderate (2), as the hazard is theoretical and no adverse health consequences are reported.
Plain-English summary
Biomerieux Inc is recalling 1,524 kits of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602). 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 are Lots 745363420 (exp. 11/25/16) and 745375920 (exp. 3/30/17). These kits were distributed in the Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
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 stop using the affected lots and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 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
- 1,524
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 (1)
- Lots 745363420 exp. 11/25/16 and 745375920 exp. 3/30/17.
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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