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 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 adverse health consequences or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 1,505 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N331), REF 418675. 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 codes associated with the recall are 7710138203 (dated 13/Apr/18) and 7710205203 (dated 19/Jun/18).
Healthcare facilities and users should stop using the affected cards and contact Biomerieux Inc for further instructions or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N331), IVD, REF 418675, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,505
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)
- 7710138203 13/Apr/18 7710205203 19/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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