Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
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, but the source text describes a theoretical risk of antibiotic degradation due to moisture exposure without reporting any specific illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or theoretical hazards.
Plain-English summary
Biomerieux Inc is recalling 9,817 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN16), REF 22139. The recall is due to a potential compromise in the integrity of the product container, which may expose the cards to moisture. This exposure could lead to antibiotic degradation and 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 affected are 1130069203, 1130173203, 1130192103, 1130227203, and 1130266103.
Healthcare facilities and consumers should stop using the affected product and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 9,817
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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