MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-160
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation is in progress.A supplemental report will be provided pending completion, or upon receipt of new information.
Event or Problem Description
The consumer reported a single false positive result with the binaxnow covid-19 ag self test performed on (b)(6) 2026.Initial testing had been performed on (b)(6) 2026 using a poc sars-covid-2 ag test (brand/type unknown) at doctor's office and on (b)(6) 2026 using binaxnow covid-19 ag self test at medical clinic, both tests generated negative results.No information regarding confirmatory testing was provided.The consumer reported feeling tired as the symptom present at the time of testing.The consumer confirmed there was no patient harm due to the test results.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 2CT
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• 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: 24662807
• Report Number: 1221359-2026-00035
• Device Sequence Number: 13061012
• Product Code: QYT
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081726062710000911485A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: Lay User/Patient
• Device Expiration Date: 06/27/2026
• Device Catalogue Number: 195-160
• Device Lot Number: 000911485A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Black Or African American