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.
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 48,371 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN69), REF 413400. The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure may lead to antibiotic degradation, resulting in a loss of potency.
The affected products were distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations. The recall covers specific lot numbers with expiration dates ranging from May 2018 to September 2018.
Consumers and healthcare facilities should stop using the affected cards and contact Biomerieux Inc for further instructions or a refund.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 48,371
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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