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 and loss of potency.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a loss of potency due to moisture, which is a functional defect rather than a direct physical injury or acute toxicity risk, fitting the Moderate severity criteria for low-risk contamination or functional issues without reported injury.
Plain-English summary
Biomerieux Inc is voluntarily recalling 6,320 VITEK 2 Gram Positive Susceptibility cards (AST-P631, REF 414961). The recall is due to a potential defect where the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation, resulting in a loss of potency in the susceptibility cards.
The affected products were distributed nationwide in the United States, including to military and government sites. The recall also covers products distributed to numerous international locations, including Canada, the United Kingdom, Australia, and various countries in Europe, Asia, Africa, and the Americas. The specific lot codes associated with this recall are 7310166103 (11/May/18), 7310187103 (01/Jun/18), and 7310221103 (05/Jul/18).
Healthcare facilities and users should check their inventory for these specific lot codes and stop using the affected cards. Biomerieux Inc is the recalling firm responsible for managing this recall. No specific instructions for disposal or return are provided in the source text, but users should contact the manufacturer for further guidance on handling the recalled items.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 6,320
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)
- 7310166103 11/May/18 7310187103 01/Jun/18 7310221103 05/Jul/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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