Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity 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. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure. No illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling 1,490 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P646), REF 420144. The recall involves 20 cards per carton.
The recall is being issued because the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation, resulting in a loss of potency. The product is an in vitro diagnostic (IVD) device used for susceptibility testing.
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. Users should stop using the product and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,490
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)
- 7460116203 22/Mar/18 7460194203 08/Jun/18 7460236203 20/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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