ETEST® Fluconazole (FL)Recalls & reported problems
Biomerieux SA · Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions for MIC determination. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Nov 9, 2022Open, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0824-2023 · Root cause: Storage · Recall details · FDA record ↗
Other Susceptibility Test Plate, Antifungal devices
- NA Y3462Remel, Inc. · Susceptibility Test Plate, Antifungal1 recall0 reports
- VITEK® 2 AST-YS09Biomerieux , Inc. · SUSCEPTIBILITY TEST PLATE, ANTIFUNGAL1 report
- 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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