Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers 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 617 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N314), REF 417027. The product is an in vitro diagnostic (IVD) device used for testing antibiotic susceptibility.
The recall was initiated because the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation and a loss of potency in the test cards.
The affected product was distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations. Users of the product should contact Biomerieux Inc for further instructions on how to proceed.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 617
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)
- 7540145203 20/Apr/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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