Biomerieux Recalls VITEK 2 Gram Streptococcus Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Streptococcus 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: This is a voluntary precautionary recall for a potential loss of potency due to moisture exposure, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Biomerieux Inc is voluntarily recalling VITEK 2 Gram Streptococcus Susceptibility cards (AST-ST01), REF 410028. The recall involves 19,398 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 specific lot codes and expiration dates ranging from March 2018 to September 2018.
Healthcare facilities and distributors should stop using the affected product and contact Biomerieux Inc for further instructions. Consumers are not directly affected as this is a professional medical device used in clinical laboratories.
The recalled product
- Product
- VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
- Manufacturer
- Biomerieux Inc
- Affected units
- 19,398
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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