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 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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical loss of potency due to moisture exposure, which aligns with the criteria for a moderate severity score.
Plain-English summary
Biomerieux Inc is recalling 3,419 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N355), REF 421351. The recall is due to a potential compromise in the integrity of the product container, which may expose the product 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 source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities and users 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-N355), IVD, REF 421351, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 3,419
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 7950149203 24/Apr/18 7950197203 11/Jun/18 7950243403 27/Jul/18
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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