Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or acute toxic hazard, fitting the Moderate severity criteria for low-risk contamination or functional issues without reported injury.
Plain-English summary
Biomerieux Inc is recalling 1,017 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P640), REF 418579. The recall is due to a potential compromise in the integrity of the product container. This defect may expose the product to moisture, which could lead to antibiotic degradation and a loss of potency.
The affected product was distributed nationwide in the United States, including to military and government sites. It was also distributed to numerous international locations, including Canada, the United Kingdom, Australia, and many countries in Europe, Asia, Africa, and the Americas.
Users should stop using the recalled cards and contact Biomerieux Inc for further instructions or a replacement. The recall number is Z-2487-2017.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,017
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)
- 7400144203 19/Apr/18
Distribution
Part of a larger recall action
This product is one of 187 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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Similar recalls
- HighbioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards
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