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 FDA classified this as a Class II recall. 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 'Moderate' criteria for low-risk contamination or functional issues without reported injury.
Plain-English summary
Biomerieux Inc is recalling 696 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-GN91), REF 414780. 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 was initiated 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 6810153203 (dated 28/Apr/18) and 6810244203 (dated 28/Jul/18).
Healthcare facilities and consumers should stop using the affected products and contact Biomerieux Inc for further instructions or a refund. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-GN91), REF 414780, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 696
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)
- 6810153203 28/Apr/18 6810244203 28/Jul/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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