Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity 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 or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards (AST-GP67), REF 22226. The recall involves 75,502 cartons, with 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 specific illnesses or injuries associated with this recall.
Healthcare facilities and consumers should stop using the affected cards and contact Biomerieux Inc for further instructions or a return. The recall covers specific lot codes and dates ranging from May 2018 to September 2018.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 75,502
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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