Biomerieux Vitek 2 Fungal Susceptibility Cards Recalled for QC Failures
Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards due to Out-of-Range-Low Flucytosine QC results for Candida krusei.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a quality control failure in a medical diagnostic device that could lead to inaccurate clinical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomerieux Inc is recalling Vitek 2 AST-YS07 Fungal Susceptibility Cards, an in vitro diagnostic (IVD) product intended for use with Vitek 2 Systems in clinical laboratories. The cards are used to determine the susceptibility of clinically significant yeasts to antifungal agents.
The recall was initiated because the test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. This quality control failure may affect the accuracy of the test results.
A total of 43,535 20-card cartons were distributed to foreign subsidiaries and distributors, including in Canada and Mexico. The affected lots were manufactured between April 2015 and July 2016. Clinical laboratories and distributors should stop using the affected products and contact Biomerieux Inc for instructions on return or replacement.
The recalled product
- Product
- Vitek 2 AST-YS07 REF 414 967, 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 instr
- 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 (20)
- lot 287303120
- 02-APR-15
- lot 287303122
- lot 287306710
- 08-MAY-15
- lot 287308210
- 23-MAY-15
- lot 287311710
- 27-JUN-15
- lot 287314910
- 29-JUL-15
- lot 287314912
- lot 287315710
- 06-AUG-15
- lot 287317310
- 22-AUG-15
- lot 287317710
- 26-AUG-15
- lot 287318920
- 07-SEP-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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