Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity 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 hospitalizations, injuries, or illnesses. 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 1,186 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-XN05, REF 413230). The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure may 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 codes associated with this recall are 1480204103, 1480243203, and 1480248203.
Users of this product should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-XN05), REF 413230, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,186
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)
- 1480204103 18/Jun/18 1480243203 27/Jul/18 1480248203 01/Aug/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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