Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors
Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produce Out-of-Range-Low Flucytosine QC results for Candida krusei. The affected products were distributed to foreign subsidiaries and distributors.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific issue is a quality control error in the test kit, not a direct physical hazard to the patient, and no illnesses or injuries are reported.
Plain-English summary
Biomerieux Inc is recalling specific lots of Vitek 2 AST-YS01 REF 22 108 Fungal Susceptibility Cards. 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 involves 1,604 20-card cartons from lots 281317710, 281347810, and 281350120.
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 issue may affect the reliability 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. Clinical laboratories and distributors should stop using the affected lots and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- Vitek 2 AST-YS01 REF 22 108, 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 instru
- Manufacturer
- Biomerieux Inc
- Hazard
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 (6)
- lot 281317710
- 26-AUG-15
- lot 281347810
- 22-JUN-16
- and lot 281350120
- 15-JUL-16.
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Biomerieux Inc
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · quality control error
See all →- ModerateImmunoassay Quality Control Material Recalled for Out-of-Range Values
FDA (Devices) · 2023-07-05
- ModerateFDA Recalls Immunoassay Quality Control Material for Out-of-Range Values
FDA (Devices) · 2023-07-05
- LowIntegra NeuraGen Nerve Guide Recalled for Quality Control Error
FDA (Devices) · 2020-03-18
- ModerateOrtho Vitros Myoglobin Calibrators Recalled for Stability Issues
FDA (Devices) · 2019-02-27
- ModerateBiomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors
FDA (Devices) · 2015-05-20