Biomerieux Recalls VITEK 2 Yeast Identification Cards Due to Container Integrity Issues
Biomerieux Inc is recalling VITEK 2 Yeast identification cards because compromised containers 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. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or acute toxic exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling VITEK 2 Yeast identification cards (YST), In Vitro Diagnostic (IVD), REF 21343. The recall involves 5,192 cartons, with 20 cards per carton. The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations.
The recall was initiated because the integrity of the product container may be compromised. This defect could expose the product to moisture, which may lead to antibiotic degradation and a loss of potency. No specific lot numbers or expiration dates are provided in the source text, though code information indicates dates of 13/Jun/18.
Healthcare facilities and consumers who have purchased or received these products should stop using them and contact Biomerieux Inc for further instructions or a refund. The recall is classified as Class II by the FDA.
The recalled product
- Product
- VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .
- Manufacturer
- Biomerieux Inc
- Affected units
- 5,192
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)
- 2430199103 13/Jun/18 2430199123 13/Jun/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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