Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
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, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
Biomerieux Inc is recalling 426 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P645), REF 419602. The recall is due to a potential compromise in the integrity of the product container, which may expose the cards 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 specific lot code for the recalled product is 7450130203, with a date of 05/Apr/18.
Healthcare facilities and users should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-P645), IVD, REF 419602, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 426
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)
- 7450130203 05/Apr/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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