Biomerieux Recalls VITEK 2 Gram Fungal Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, leading to 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, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Gram Fungal Susceptibility cards (AST-YS07), REF 414967, due to a potential defect in the product container. The integrity of the container may be compromised, which could expose the product to moisture. This exposure may lead to antibiotic degradation and a loss of potency.
The recall affects 12,738 cartons of the product. The cards were distributed nationwide in the United States, including to military and government sites, as well as to numerous international locations. The product is an in vitro diagnostic (IVD) used for testing.
No specific instructions for consumers are provided in the source text, as this is a medical device recall typically managed through healthcare facilities and distributors.
The recalled product
- Product
- VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 12,738
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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Similar recalls
- ModerateBiomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors
FDA (Devices) · 2015-05-20
- HighBiomerieux Vitek 2 Fungal Susceptibility Cards Recalled for QC Failures
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