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, and the hazard involves potential loss of potency due to moisture exposure rather than direct injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Biomerieux Inc is voluntarily recalling 4,709 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N208), REF 413062. 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 United States, including to military and government sites. It was also 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 5780224103, 5780255103, and 5780275103.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N208), IVD, REF 413062, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 4,709
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)
- 5780224103 08/Jul/18 5780255103 08/AUG/18 5780275103 28/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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