Biomerieux Recalls Vitek 2 AST-P641 Cards Due to Labeling Error
Biomerieux Inc is recalling Vitek 2 AST-P641 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error.
Plain-English summary
Biomerieux Inc is recalling 1,505 cartons of Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Cards. The recall is due to a labeling error where the outer carton and package insert incorrectly list Streptococcus pneumoniae as an organism for intended use. 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.
The affected lots are 741350820 (expiration 22JUL16) and 741340920 (expiration 14APR16). The product was distributed worldwide to the United Kingdom and Turkey. There was no distribution to the United States.
This is a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences. Clinical laboratories should stop using the affected cards and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, 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
- 1,505
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 741350820
- expiration 22JUL16
- lot 741340920
- expiration 14APR16
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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