Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive 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 recall is classified as FDA Class II, but the hazard is theoretical (potential loss of potency due to moisture) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards (AST-P642), REF 418604. The recall involves 2,468 cartons, with 20 cards per carton. The product is an in vitro diagnostic (IVD) device used for susceptibility testing.
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 product was distributed nationwide in the U.S., including to military and government sites, as well as to numerous international locations.
Healthcare facilities and other recipients should stop using the affected product and contact Biomerieux Inc for further instructions on return or disposal.
The recalled product
- Product
- VITEK¿ 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 2,468
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)
- 7420116203 22/Mar/18 7420123203 29/Mar/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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