Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and 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 or high-risk pathogen exposure. No illnesses or injuries are reported.
Plain-English summary
Biomerieux Inc is recalling 512 cartons of VITEK 2 Gram Negative Susceptibility cards (AST-N217), REF 413080. 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 defect could expose the product to moisture, which may lead to antibiotic degradation and a loss of potency. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected product. Users should check their inventory for the specific reference number 413080 and the code 6170132203 07/Apr/18. For further instructions, users should contact Biomerieux Inc.
The recalled product
- Product
- VITEK¿ 2 Gram Negative Susceptibility card (AST-N217), REF 413080, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 512
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)
- 6170132203 07/Apr/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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