VITEK® 2 AST-YS09Recalls & reported problems
Biomerieux , Inc. · The VITEK 2 ® Yeast Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant yeast. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026619350), received between Oct 6, 2022 and Oct 6, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Low Test Results” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Low Test Results1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2022Low Test Results; Low Test Results
INTENDED USE: THE VITEK® 2 FUNGAL SUSCEPTIBILITY CARD IS 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 INSTRUCTED. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE SUSCEPTIBLE FLUCONAZOLE RESULT FOR CANDIDA ALBICANS WHILE ANALYZING A PATIENT SAMPLE WITH THE VITEK® 2 AST-YS09 TEST KIT (REF (B)(4), LOT 2892048203). THE CUSTOMER REPORTED THAT THEY OBTAINED A FLUCONAZOLE SUSCEPTIBLE RESULT WITH THE VITEK 2 AST-YS09 TEST KIT. THE PATIENT WAS TREATED WITH FLUCONAZOLE FOR TWO WEEKS BASED ON THE SUSCEPTIBLE RESULT. AFTER TWO WEEKS, THE PATIENT WAS NOT IMPROVING, SO THE TREATING PHYSICIAN REQUESTED THAT THE ISOLATE BE SENT TO A REFERENCE LABORATORY FOR ADDITIONAL TESTING. THE REFERENCE LABORATORY OBTAINED FLUCONAZOLE RESISTANT RESULTS. THE CUSTOMER THEN ALSO TESTED THE ISOLATE WITH A FLUCONAZOLE ETEST® STRIP AND OBTAINED RESISTANT RESULTS. TREATMENT WAS CHANGED FROM FLUCONAZOLE TO A DIFFERENT DRUG AFTER THE RESISTANT RESULTS WERE REPORTED. INITIAL VITEK 2: FLUCONAZOLE MIC <= 0.5 MG/L (SUSCEPTIBLE). REPEAT VITEK 2: F
Patient problems: Insufficient Information
MAUDE report 15555763 ↗
Other SUSCEPTIBILITY TEST PLATE, ANTIFUNGAL devices
- NA Y3462Remel, Inc. · Susceptibility Test Plate, Antifungal1 recall0 reports
- ETEST® Fluconazole (FL)Biomerieux SA · Susceptibility Test Plate, Antifungal1 recall0 reports
- Etest® ITRACONAZOLEBiomerieux SA · Susceptibility Test Plate, Antifungal1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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