Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative 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 without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 8,417 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-XN06, REF 413944). 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.
The affected product was distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations. The specific lot codes associated with this recall are 1490195103, 1490224203, 1490244103, and 1490267203.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-XN06), REF 413944, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 8,417
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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