MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. ALETHIA

Catalog Number	610189
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit is unavailable for further evaluation as the customer had confirmed to discard the instrument and its components in accordance with applicable policies, local environmental regulations, and safety requirements.
Event or Problem Description
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.

• Brand Name: ALETHIA
• Common Device Name: ALETHIA
• 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: 23605410
• Report Number: 1524213-2025-00006
• Device Sequence Number: 18456232
• Product Code: OOI
• UDI-Device Identifier: 00840733101663
• UDI-Public: 00840733101663
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 610189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2019
• 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