Biomerieux Recalls Vitek 2 AST-P640 Cards Due to Labeling Error
Biomerieux Inc is recalling Vitek 2 AST-P640 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding intended use organisms.
Plain-English summary
Biomerieux Inc is recalling 2,053 cartons of Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Cards. These in vitro diagnostic (IVD) cards are intended for use with Vitek 2 Systems in clinical laboratories to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
The recall was initiated because the outer carton label and package insert incorrectly list Streptococcus pneumoniae as an organism for intended use. The affected lots are 740340920 (expiration 14APR16) and 740350820 (expiration 22JUL16).
The product was distributed worldwide to the United Kingdom and Turkey. There is no U.S. distribution for this recall. Clinical laboratories and distributors in the affected regions should stop using the product and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 2,053
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 (4)
- lot 740340920
- expiration 14APR16
- lot 740350820
- expiration 22JUL16
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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