Alethia™ 610189Recalls & reported problems
Meridian Bioscience, Inc. · Alethia™ is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc.’s Alethia Loop-Mediated Amplification assays. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840733101663), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025No Apparent Adverse Event; No Apparent Adverse Event
ON (B)(6) 2025, MERIDIAN BIOSCIENCE INC. WAS FORWARDED INFORMATION RELATED TO AN INCIDENT INVOLVING A CUSTOMER LOCATED IN AUSTRALIA. CUSTOMER HAD TURNED THE ALETHIA INSTRUMENT OFF TO COMPLETE THE REQUIRED CLEANING PROCEDURE. THE UNIT WAS TURNED BACK ON TO RESUME USE. DURING NORMAL USE, AFTER THE UNIT IS TURNED ON, THE BLOCKS AUTOMATICALLY START TO WARM UP TO OPERATING TEMPERATURE. TEST RUNS ARE UNABLE TO BE INITIATED UNTIL THE COMPLETION OF THIS WARMUP PERIOD. DURING THIS WARMUP PERIOD, IT WAS IDENTIFIED THAT ONLY BLOCK A WAS WARMING UP. SHORTLY AFTER, THE SCREEN WENT OFF, THERE WAS A 'POP SOUND' AND THEN A SMELL OF ELECTRICAL BURN FROM AC ADAPTOR ON THE POWER CORD. THE CUSTOMER SWITCHED THE INSTRUMENT OFF, WAITED 15-20 MINUTES, AND TRIED AGAIN, BUT THE SMELL PERSISTED SO THEY DECIDED TO FULLY SHUT IT DOWN AND NOT TURN IT ON AGAIN. THE CUSTOMER THEN WITHDREW THE INSTRUMENT FROM OPERATIONAL USE. WHILE THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM REPORTED, MERIDIAN HAS ELECTED TO SUBMIT THIS REPORT OUT OF AN EXTREME ABUNDANCE OF CAUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605410 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.