Revogene 610210Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840733102318), received between Aug 26, 2021 and Nov 26, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (5 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 22, 2022Open, Classified

   When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.

   Z-1479-2022 · Root cause: Device Design · FDA record ↗

2. Feb 15, 2022Open, Classified

   The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.

   Z-0836-2022 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON NOVEMBER 3, 2025, MERIDIAN BIOSCIENCE INC. TECHNICAL SERVICE DEPARTMENT RECEIVED A CALL FROM A CUSTOMER WHO REPORTED ABORTING A RUN AFTER HEARING A LOUD NOISE AND SMELLING A BURNING SMELL. THE CUSTOMER DID NOT SEE ANY SMOKE OR FEEL ANY HEAT, AND NO ONE WAS INJURED. WHILE THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM WERE 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 23658911 ↗
• MalfunctionNov 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, MERIDIAN BIOSCIENCE INC. TECHNICAL SERVICE DEPARTMENT RECEIVED A CALL FROM A CUSTOMER WHO REPORTED A FULL RUN OF INDETERMINATE RESULTS OBTAINED DURING TESTING WITH THE REVOGENE GROUP A STREP ASSAY. CUSTOMER ALSO REPORTED A BURNING SMELL DURING THE RUN. WHEN THE RUN WAS COMPLETED, THE CUSTOMER OBSERVED THAT THE MICROFLUIDIC PIES WERE MELTED. CUSTOMER HAD THEIR CLINICAL ENGINEERING DEPARTMENT CHECK THE OUTLET AND THE CIRCUIT THE REVOGENE WAS PLUGGED INTO AND EVERYTHING CHECKED OUT OK. CUSTOMER DID NOT OBSERVE ANY VISIBLE DAMAGE TO THE INSTRUMENT OTHER THAN THE MELTED PIES. WHILE THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM WERE 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 23480262 ↗
• MalfunctionJun 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON SEPTEMBER 14, 2020, CUSTOMER CALLED TECHNICAL SUPPORT (TS) AND REPORTED DURING A RUN ON A REVOGENE INSTRUMENT THEY SMELLED A BURNING ODOR. CUSTOMER STATED THAT THEY IMMEDIATELY ABORTED THE RUN ON THE REVOGENE INSTRUMENT. TS INFORMED THEM THAT A BURNING SMELL IS TYPICALLY A PIE RUBBING AGAINST THE INSIDE OF THE REVOGENE INSTRUMENT BECAUSE IT ISN'T SEATED PROPERLY. REVOGENE INSTRUMENT WAS ON A CABINET WHICH MAY NOT BE STABLE ENOUGH FOR THE REVOGENE INSTRUMENT. THE REVOGENE INSTRUMENT WAS MOVED TO A COUNTER AND ANOTHER INSTRUMENT MOVED TO THE CABINET. CUSTOMER IS SATISFIED WITH TS ASSISTANCE. IT IS A KNOWN FAILURE MODE THAT IMPROPERLY SETTING PIES IN THE ROTOR CAN LEAD TO A "BLOCKED ROTOR" AND LEFT UNATTENDED CAN RESULT IN THE SMELL OF HEATED PLASTIC; HOWEVER, THE INSTRUMENT WILL SHUT DOWN IF THE ROTOR BECOMES BLOCKED. THE PRODUCT LABELING DESCRIBES THE IMPORTANCE OF SEATING PIES IN THE ROTOR PROPERLY. THIS COMPLAINT WAS FOUND AS PART OF A REVIEW FOR MDR 1524213-2024-00001 AND AFTER CAREFUL REVIEW, MERIDIAN HAS ELECTED TO REPORT OUT OF AN EXTREME ABUNDANCE OF CAUTION. THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM AS A RESULT OF THE BURNING SMELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331330 ↗
• MalfunctionJun 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON MAY 7, 2020, CUSTOMER CALLED TECHNICAL SUPPORT (TS) AND REPORTED HEARING A LOUD NOISE DURING A TEST RUN ON A REVOGENE INSTRUMENT AND THEN SMELLED A BURNING ODOR. CUSTOMER STATED THAT SHE IMMEDIATELY TURNED OFF THE REVOGENE INSTRUMENT. TS INSTRUCTED CUSTOMER TO TURN THE REVOGENE INSTRUMENT BACK ON IN ORDER TO OPEN THE LID TO SEE IF A PIE WAS DISLODGED, AS THIS COULD POTENTIALLY CAUSE THE SERIES OF EVENTS THAT WERE BEING REPORTED. CUSTOMER STATED THAT SHE WAS PERFORMING ONE PATIENT TEST AND THE REST WERE MOCK PIES. TS ASKED CUSTOMER IF MOCK PIES ARE REMOVED AFTER EACH TEST RUN AND CUSTOMER STATED THAT, YES, THEY WERE. ONCE THE LID WAS OPENED, CUSTOMER STATED THAT THE PIE CONTAINING THE PATIENT SAMPLE APPEARED TO BE SLIGHTLY RAISED. TS ADVISED CUSTOMER TO CHECK THAT ALL PIES ARE SECURE, EVEN AFTER PUTTING RETENTION RING IN PLACE. TS ALSO ADVISED CUSTOMER TO ENSURE THAT THE SENSORS ON THE LID DO NOT APPEAR TO HAVE MATERIAL COATING THEM AS A RESULT OF THE DISLODGED PIE, AND IF SO, TO WIPE THEM OFF WITH ALCOHOL. TS ADVISED CUSTOMER THAT SHE WILL NEED TO REPEAT THE PATIENT TEST FROM THE BEGINNING AS THE PIE CAN NOT BE REUSED. CUSTOMER TO REPEAT TESTING. CUSTOMER REPORTED THAT REPEAT TE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331257 ↗
• MalfunctionAug 19, 2022Temperature Problem

  THE CUSTOMER REPORTED THAT THE INSTRUMENT BEGAN ABORTING RUNS. UPON THE FIRST ABORTED PATIENT RUN (ON (B)(6) 2022), THE CUSTOMER NOTED THAT THE INSTRUMENT WAS "SUPER-HOT" INSIDE OF THE LID. THE CUSTOMER THEN EXPERIENCED AN ABORTED PATIENT RUN ON (B)(6) 2022 AND THE NOTED THE INSTRUMENT WAS "UNUSUALLY WARM" ON THE INSIDE OF THE LID. THE INSTRUMENT ALSO ABORTED A PATIENT RUN ON (B)(6) 2022. MERIDIAN BECAME AWARE OF THIS EVENT ON (B)(6) 2022. WHILE NO CLAIMS OF INJURY OR BURNS WERE REPORTED WITH EACH OCCURRENCE, MERIDIAN HAS ELECTED TO SUBMIT THIS REPORT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258669 ↗
• MalfunctionJun 15, 2022Temperature Problem

  THE CUSTOMER REPORTED THE INSTRUMENT BECAME HOT (NOT BURNING BUT HAD NEVER FELT THAT WARM BEFORE). WHILE NO REPORTS OF INJURIES OR BURNS WERE MADE, MERIDIAN BIOSCIENCE HAS ELECTED TO SUBMIT THIS MDR OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14700242 ↗
• MalfunctionMay 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Temperature Problem

  CUSTOMER WAS EXECUTING A TEST RUN WITH THE REVOGENE INSTRUMENT, CATALOG 610210. CUSTOMER HAD OBTAINED INDETERMINATE RESULTS AFTER RECEIVING ERROR CODE 037-014. AFTER THE INDETERMINATE RESULTS WERE RECEIVED THE CUSTOMER OPENED THE LID AND NOTED THAT UNDERNEATH THE LID WAS HOT TO THE TOUCH. WHILE THERE WERE NO REPORTED INJURIES OR BURNS ASSOCIATED WITH THIS EVENT, MERIDIAN BIOSCIENCE INC HAS ELECTED TO SUBMIT THIS MDR OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14452847 ↗
• MalfunctionMay 19, 2022Output Problem; Temperature Problem

  CUSTOMER WAS EXECUTING A TEST RUN WITH THE REVOGENE INSTRUMENT, CATALOG 610210. THE RUN WAS ABORTED AFTER ERROR CODE 037-014 WAS RECEIVED. THE CUSTOMER REPORTED THAT AFTER THE ABORTED RUN, THE INSTRUMENT WAS VERY WARM. WHILE THERE WERE NO REPORTED INJURIES OR BURNS ASSOCIATED WITH THIS EVENT, MERIDIAN BIOSCIENCE INC. HAS ELECTED TO SUBMIT THIS MDR OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434250 ↗
• MalfunctionOct 14, 2021Output Problem

  ON (B)(6) 2021, A MERIDIAN TECHNICAL SERVICE REPRESENTATIVE WAS AT THE CUSTOMER SITE ASSISTING WITH INSTRUMENT INSTALLATION. DURING INSTALLATION, A SELF-TEST WAS INITIATED. CONTINUED ON PAGE 3.

  Patient problems: Insufficient Information

  MAUDE report 12632718 ↗
• MalfunctionAug 26, 2021Melted; Smoking; Difficult to Open or Close; Temperature Problem

  CUSTOMER WAS COMPLETING A TEST RUN UTILIZING 3 PREPARED REVOGENE GROUP A STREP TEST DEVICES AND 5 REVOGENE MOCKPIES. THE CUSTOMER REPORTED THAT THE INSTRUMENT ABORTED THE TEST RUN AFTER SMOKE APPEARED FROM THE INSTRUMENT. THE LID WAS DIFFICULT TO OPEN AND THE RETENTION RING WAS VERY WARM. THE PIES SHOWED SIGNS OF MELTING. THERE WERE NO INJURIES OR LABORATORY DAMAGE REPORTED. WHILE THERE WAS NO INJURIES OR DETERIORATION OF HEALTH REPORTED WITH THIS INCIDENT, THIS INCIDENT HAS THE POTENTIAL TO CAUSE A BURN THROUGH ACCIDENTAL CONTACT WITH THE HEATED INSTRUMENT COMPONENTS OR MELTED PIES. IMPACT OF BURNS COULD RANGE FROM MINOR SEVERITY TO SERIOUS INJURY DEPENDING ON THE LOCATION AND DURATION OF CONTACT. THE INABILITY TO COMPLETE THE TEST RUN COULD LEAD TO AN INABILITY TO PRESCRIBE NECESSARY TREATMENT. SYMPTOMS COULD PROGRESS AND THE DISEASE STATE MAY WORSEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374693 ↗