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, but the hazard is limited to potential loss of potency due to moisture exposure rather than direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or precautionary measures.
Plain-English summary
Biomerieux Inc is recalling 1,029 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N297), REF 415672. The product is an in vitro diagnostic (IVD) device used for susceptibility testing.
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. The agency classifies this as a Class II recall.
The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations. Users should stop using the affected product and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,029
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)
- 7170138203 13/Apr/18 7170145203 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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