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	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B2: event date: date is an approximation as the exact date of the event was not reported.The investigation is ongoing; a supplement report will be sent upon completion.
Event or Problem Description
The consumer reported a false positive result with the binaxnow covid-19 self-test on an unknown date on (b)(6) 2025.The consumer indicated that the result showed a dark pink control line and a faint pink sample line (indicates a positive result) and was unsure if the result was positive.Due to what the consumer reported as an inconclusive result, they visited an urgent care center where an unknown covid-19 rapid test was performed that presented a negative result.The consumer reported to have been symptomatic including a mild sore throat.No negative impact was reported as a result.No further information was reported.

• 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: 25056988
• Report Number: 1221359-2026-00063
• Device Sequence Number: 9399936
• Product Code: QYT
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081726040610886120
• 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): 05/13/2026

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: 04/06/2026
• Device Catalogue Number: 195-160
• Device Lot Number: 886120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2024
• 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 Sex: Unknown