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 functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
Biomerieux Inc is recalling 6,761 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N344), REF 420440. 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 this recall are 7840209103 (dated 23/Jun/18) and 7840245203 (dated 29/Jul/18).
Users of these in vitro diagnostic (IVD) cards should stop using the affected lots and contact Biomerieux Inc for further instructions or replacement. The hazard is limited to the potential loss of antibiotic potency in the test cards, which may affect the accuracy of susceptibility results.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 6,761
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)
- 7840209103 23/Jun/18 7840245203 29/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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