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 risk or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 3,665 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N213), REF 413063. 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 are identified by the codes 6130262103 (expiration date 15/Aug/18) and 6130280203 (expiration date 02/Sep/18).
Users of the product 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 the manufacturer for credit.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N213), REF 413063, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 3,665
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)
- 6130262103 15/Aug/18 6130280203 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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