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 degrading antibiotic 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 hazard is a theoretical 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 2,428 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN87), REF 413943. The recall involves specific lots with codes 6770115203, 6770153203, 6770163203, 6770217203, and 6770253203, with expiration dates ranging from March 21, 2018, to August 6, 2018.
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.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for further instructions or a return.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 2,428
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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