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 Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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 reagent exposure in her nose with the expired binaxnow covid-19 antigen self test performed on (b)(6) 2025.The consumer added 6 drops of reagent solution and inserted the swab to the bottom hole of the test card without swabbing their nose.On realization the consumer removed the swab with reagent solution and swabbed her nose with it.The consumer was advised to rinse her nose with water.The consumer confirmed there was no medical intervention.
Additional Manufacturer Narrative
A product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.
Event or Problem Description
The consumer reported reagent exposure in her nose with the expired binaxnow covid-19 antigen self test performed on (b)(6) 2025.The consumer added 6 drops of reagent solution and inserted the swab to the bottom hole of the test card without swabbing their nose.On realization the consumer removed the swab with reagent solution and swabbed her nose with it.The consumer was advised to rinse her nose with water.The consumer confirmed there was no medical intervention.

• 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: 23490944
• Report Number: 1221359-2025-00833
• Device Sequence Number: 8625266
• Product Code: QYT
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081723121510
• 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): 11/14/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/15/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 218678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: White