Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards due to potential container integrity issues that 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, and the hazard involves potential loss of potency due to moisture exposure rather than direct injury or contamination, fitting the criteria for a moderate severity recall.
Plain-English summary
Biomerieux Inc is recalling 498 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N290), REF 415058. The recall was initiated because the integrity of the product container may be compromised, potentially exposing the product to moisture. This exposure could lead to antibiotic degradation and a loss of potency.
The affected product was distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations. The specific distribution list includes countries across the Americas, Europe, Asia, Africa, and the Middle East.
Consumers and healthcare facilities should stop using the recalled cards and contact Biomerieux Inc for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N290), REF 415058, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 498
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)
- 7100188203 02/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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