Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, leading to 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, but the hazard is limited to product potency loss due to moisture exposure without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Biomerieux Inc is recalling 32,628 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN49), REF 412091. The recall involves 20 cards per carton.
The recall was initiated because the integrity of the product container may be compromised, exposing the product to moisture. This exposure could lead to antibiotic degradation and a loss of potency.
The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations. Affected lots include those with codes 4690028203, 4690167103, 4690168103, 4690187103, 4690197203, 4690208103, 4690224203, 4690229103, 4690230103, 4690237103, 4690254203, 4690265203, 4690272103, 4690277203, and 4690287203.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 32,628
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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