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. The hazard involves potential loss of potency due to moisture exposure, which is a functional defect rather than a direct physical injury or acute toxic exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
Biomerieux Inc is recalling 1,040 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN83), REF 413440. The recall involves specific lots manufactured in 2018. The product is a medical device used for antibiotic susceptibility testing.
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 cards were distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for further instructions or a replacement. The agency has classified this as a Class II recall.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN83), REF 413440, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,040
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)
- 6730188203 02/Jun/18 6730244203 28/Jul/18 6730280203 02/Sep/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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