Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative 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, but the hazard is limited to potential loss of potency due to moisture exposure without reports of hospitalization or significant injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling 5,795 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N223, REF 413110). The recall is due to a potential defect where the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation and a loss of potency in the susceptibility cards.
The affected products were distributed nationwide in the United States, including to military and government sites. The recall also covers products distributed to numerous international locations, including Canada, the United Kingdom, Australia, and various countries in Europe, Asia, Africa, and the Americas. The specific lot codes associated with this recall are 6230087203, 6230152203, and 6230279203.
Healthcare facilities and distributors should check their inventory for the affected lot codes and stop using these cards immediately. Users should contact Biomerieux Inc for further instructions on how to return or dispose of the recalled products. No specific illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N223), REF 413110, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 5,795
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)
- 6230087203 21/Feb/18 6230152203 27/Apr/18 6230279203 01/Sep/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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