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.
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 II, and the hazard involves potential loss of potency due to moisture exposure rather than direct physical injury or contamination, fitting the criteria for a moderate severity recall.
Plain-English summary
Biomerieux Inc is recalling 1,449 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P649), REF 420858. 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 various countries in Europe, Asia, Africa, and the Americas. The specific lot codes associated with the recall are 7490131203, 7490200103, and 7490236203.
Healthcare facilities and users should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-P649), IVD, REF 420858, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,449
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)
- 7490131203 06/Apr/18 7490200103 14/Jun/18 7490236203 20/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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