MAUDE Adverse Event Report: Hologic, Inc. Aptima Multitest Specimen Collection Kit; DEVICE, SPECIMEN COLLECTION

Catalog Number	ASY-08848
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction

• Brand Name: Aptima Multitest Specimen Collection Kit
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: maria osorio ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 50194697
• Report Number: 2024800-2026-00062
• Device Sequence Number: 9981083
• Product Code: LIO
• UDI-Device Identifier: 25420045510187
• UDI-Public: 25420045510187
• Combination Product (Y/N): N
• Initial Reporter State: AB
• Initial Reporter Country: US
• PMA/510(K) Number: K032554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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
• Device Catalogue Number: ASY-08848
• Device Lot Number: 935029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown