Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall for Moisture Exposure
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and 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 score.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards (AST-GN73), REF 413404, 20 cards per carton. The recall involves 11,107 cartons of the product.
The recall is being issued because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure could lead to antibiotic degradation, resulting in 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. Users should stop using the affected product and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN73), REF 413404, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 11,107
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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