Biomerieux Recalls VITEK 2 Gram-Positive Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram-Positive identification cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 without reports of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling 70,261 cartons of VITEK 2 Gram-Positive identification cards (GP), REF 21342. 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 in the identification cards.
The affected product was distributed nationwide in the United States, including to military and government sites. The product was also distributed to numerous international locations, including Canada, Mexico, the United Kingdom, and various countries in Europe, Asia, Africa, and South America. The recall covers specific lot numbers with expiration dates ranging from May 2018 to September 2018.
Healthcare facilities and distributors should stop using the affected product and contact Biomerieux Inc for instructions on return or disposal. Consumers are not directly affected as this is an in vitro diagnostic (IVD) product used in clinical laboratories.
The recalled product
- Product
- VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 70,261
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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Similar recalls
- ModerateBioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures
FDA (Devices) · 2017-09-27
- ModerateBioMérieux Recalls VITEK 2 Gram-Positive Cards Due to Temperature Excursion
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