MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. REVOGENE

Catalog Number	610210
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: REVOGENE
• Common Device Name: REVOGENE
• Manufacturer (Section D): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• Manufacturer (Section G): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• Manufacturer Contact: megan berling ; 3471 river hills dr.; cincinnati, OH 45244
• MDR Report Key: 23658911
• Report Number: 1524213-2025-00005
• Device Sequence Number: 15943127
• Product Code: OOI
• UDI-Device Identifier: 00840733102318
• UDI-Public: 00840733102318
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K243922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 610210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown