Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues 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 functional defect rather than a direct physical injury or acute toxic exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Biomerieux Inc is recalling 2,347 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N281, REF 414532). 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. It was also distributed to numerous international locations, including Canada, the United Kingdom, Australia, and various countries in Europe, Asia, Africa, and the Americas.
Users of the product should stop using the recalled cards and contact Biomerieux Inc for further instructions or a replacement.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N281), REF 414532, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 2,347
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)
- 7010066203 31/Jan/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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