MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. DETERMINE HIV-1/2 AG/AB COMBO 25T; TEST, HIV DETECTION

Catalog Number	7D2648
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported one-hundred (100) false positive results with the determine hiv 1/2 ag/ab combo test performed on an unknown date with an unknown sample type.Although requested, no specific patient information, including demographics, treatment, or impact was provided.
Additional Manufacturer Narrative
B3 - date of event: this is an approximation as the exact date of event was not reported.Investigation summary: as part of an investigation into preliminary false reactive results, abbott found that for kit lot 0000927861, the root cause of the results was due to a subcomponent used in the manufacture of determine hiv-1/2 ag/ag combo.The issue has been isolated to specific lots of the subcomponent, which were used to manufacture specific test kit lots.The necessary actions to prevent recurrence have been taken, and the correction of product in the field was conducted.

• Brand Name: DETERMINE HIV-1/2 AG/AB COMBO 25T
• Common Device Name: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 25075102
• Report Number: 1221359-2026-00160
• Device Sequence Number: 10689293
• Product Code: MZF
• UDI-Device Identifier: 00811877011101
• UDI-Public: (01)00811877011101(10)0000927861
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037
• 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: Recall
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Catalogue Number: 7D2648
• Device Lot Number: 0000927861
• 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: 04/10/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1221359-07/31/2025-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown