Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
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, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported serious injury.
Plain-English summary
Biomerieux Inc is recalling 511 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N293), REF 415369. The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure may 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 lot code associated with the recall is 7130162203, with a date of 07/May/18.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for instructions on how to return or dispose of the product. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 511
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)
- 7130162203 07/May/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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