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	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the part history file associated with the multitest swabs included in the aptima multitest swab kit (ln: 932841) confirmed that the swabs successfully passed inspection specifications.Hologic has not been informed of any adverse outcomes related to this issue.A supplier corrective action request (scar) has been issued to the supplier of the swabs (b)(4).
Event or Problem Description
On (b)(6) 2026, a customer from netherlands reported to hologic that on (b)(6) 2026, the tip of a swab, included in the aptima multitest specimen collection kit (lot number: 932841) detached from the swab shaft during rectal specimen collection and remained inside the patient.The customer stated that the patient removed the swab tip themselves.No further information on the patient¿s status was provided to hologic.Hologic has not learned of any adverse outcomes related to this event.

• 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: 25845770
• Report Number: 2024800-2026-00044
• Device Sequence Number: 16097599
• Product Code: LIO
• UDI-Device Identifier: 25420045510187
• UDI-Public: 25420045510187
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 07/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASY-08848
• Device Lot Number: 932841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/16/2026
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown