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. The hazard involves potential loss of potency due to moisture exposure, which is a quality issue rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 3,330 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N244, REF 413393). 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 products were distributed nationwide in the United States, including to military and government sites. The cards were also distributed to numerous international locations, including Canada, Mexico, and various countries in Europe, Asia, Africa, and South America.
Healthcare facilities and users should stop using the recalled cards and contact Biomerieux Inc for further instructions. 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 adverse health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N244), REF 413393, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 3,330
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)
- 6440188103 02/Jun/18 6440227103 11/Jul/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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