Biomerieux VITEK 2 Gram Negative Susceptibility Card Container Integrity Recall
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity 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 risk, and no illnesses or injuries are reported in the source text.
Plain-English summary
Biomerieux Inc is recalling 2,535 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N352), REF 421258. The recall involves specific lots with codes 7920118203, 7920164103, 7920243403, and 7920272103, manufactured between March and August 2018.
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 product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations. Users should check their inventory for the specific lot codes listed in the recall notice. If the product is found, it should be removed from use and returned to Biomerieux Inc or the distributor.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 2,535
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.
See all 187 products in this recall →Related recalls
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Similar recalls
- HighbioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards
FDA (Devices) · 2016-05-11
- ModerateBiomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives
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- SevereBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error
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- LowBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error
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