Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors
Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produced Out-of-Range-Low Flucytosine QC results for Candida krusei.
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 is a quality control error in an in vitro diagnostic test, which is a low-risk contamination or labeling/accuracy issue without reported injuries or illnesses, fitting the Moderate criteria.
Plain-English summary
Biomerieux Inc is recalling 1,025 cartons of Vitek 2 AST-YS06 REF 412 610 Fungal Susceptibility Cards. The recall is limited to lot 286303720, which has an expiration date of 08-APR-15. These in vitro diagnostic (IVD) cards are intended for use with Vitek 2 Systems in clinical laboratories to determine the susceptibility of clinically significant yeasts to antifungal agents.
The recall was initiated because the test kits produced Out-of-Range-Low (OORL) Flucytosine quality control (QC) results for Candida krusei ATCC 6258. This specific quality control failure indicates a potential issue with the accuracy of the test results for this specific organism and antifungal agent.
The affected products were distributed only to foreign subsidiaries and distributors, including in Canada and Mexico. The source text does not specify actions for individual consumers, as the products are intended for clinical laboratory use. Clinical laboratories should stop using the affected lot and contact the manufacturer for instructions.
The recalled product
- Product
- Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instruc
- Manufacturer
- Biomerieux Inc
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 (2)
- lot 286303720
- expiration 08-APR-15
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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