NA Y3462Recalls & reported problems
Remel, Inc. · 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
- Mar 24, 2026Open, Classified
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Z-1806-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Susceptibility Test Plate, Antifungal devices
- ETEST® Fluconazole (FL)Biomerieux SA · 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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