Biomerieux Recalls VITEK 2 Neisseria-Haemophilus Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Neisseria-Haemophilus identification cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotics.
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 a theoretical loss of potency due to moisture exposure without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 Neisseria-Haemophilus identification cards (NH), In Vitro Diagnostics (IVD), REF 21346. The recall involves 4,125 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 exposure to moisture could lead to antibiotic degradation, resulting in a loss of potency. The affected lots have expiration dates ranging from April 2018 to September 2018.
Healthcare facilities and consumers who have this product should stop using it and contact Biomerieux Inc for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 4,125
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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