Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised containers may expose the product to moisture, potentially causing antibiotic degradation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 minor labeling or low-risk contamination issues.
Plain-English summary
Biomerieux Inc is recalling 2,458 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-GP76), Reference 418424. The recall involves specific lots with codes 2760186403, 2760241203, and 2760255203.
The recall was initiated because the integrity of the product container may be compromised. This defect could expose the product to moisture, which may lead to antibiotic degradation and a loss of potency. The product is an in vitro diagnostic (IVD) device used for susceptibility testing.
The affected products were distributed nationwide in the United States, including to military and government sites. The products were also distributed to numerous international locations. Users should check their inventory for the specific lot codes listed and stop using the affected products if found.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 2,458
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)
- 2760186403 31/May/18 2760241203 25/Jul/18 2760255203 08/Aug/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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