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 rather than direct injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling 1,192 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN48), REF 412090. 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 and a loss of potency in the susceptibility cards.
The affected product was distributed nationwide in the United States, including to military and government sites. The recall also covers distribution to numerous international locations, including Canada, Mexico, and various countries across Europe, Asia, Africa, and South America.
Healthcare facilities and distributors should stop using the affected product and contact Biomerieux Inc for further instructions. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,192
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)
- 4680209103 23/Jun/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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