Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, leading to 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 high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported injury.
Plain-English summary
Biomerieux Inc is recalling 948 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N292), REF 415063. The recall involves 20 cards per carton. The product was distributed nationwide in the U.S., including military and government sites, as well as to numerous international locations.
The recall is being conducted because the integrity of the product container may be compromised. This exposure to moisture could lead to antibiotic degradation, resulting in a loss of potency. The affected lots have codes 7120144203 (dated 19/Apr/18) and 7120194203 (dated 08/Jun/18).
Users of these products should check their inventory for the specific reference number and lot codes listed above. If the product is found, it should be removed from use and returned to the supplier or manufacturer for credit or replacement.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N292), REF 415063, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 948
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)
- 7120144203 19/Apr/18 7120194203 08/Jun/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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