MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 4CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-180
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported a false positive result with the binaxnow covid-19 ag self test on (b)(6) 2025.The consumer received a positive result on (b)(6) 2025 and a negative result on (b)(6) 2025 with the binaxnow covid-19 ag self test.Further testing was done on (b)(6) 2025 with an unknown brand, which gave a negative result.On (b)(6) 2025, the consumer performed another test with the binaxnow covid-19 ag self test and generated a negative result.The consumer was symptomatic.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
The investigation remains in progress.A supplemental report will be provided after completion.
Additional Manufacturer Narrative
Correction: a1 - patient identifier.B3 - date of event.B5 - describe event or problem.D4 - primary udi number.H6 - adverse event problem (medical device problem code).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 false negative result with the binaxnow covid-19 ag self test performed on (b)(6) 2025.This mfr.Report addresses the testing conducted for the consumer.Initial testing was performed using both the binaxnow covid-19 ag self test and an unknown test brand on separate dates.The consumer tested positive with the binaxnow test on 06sep2025 and 09sep2025 and also tested positive with the unknown test brand on 12sep2025.The consumer confirmed there was no patient harm due to the test results.
Event or Problem Description
The consumer reported false negative result with the binaxnow covid-19 ag self test performed on (b)(6) 2025.This mfr.Report addresses the testing conducted for the consumer.Initial testing was performed using both the binaxnow covid-19 ag self test and an unknown test brand on separate dates.The consumer tested positive with the binaxnow test on (b)(6) 2025 and (b)(6) 2025 and also tested positive with the unknown test brand on (b)(6) 2025.The consumer confirmed there was no patient harm due to the test results.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 000913270a with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-180/lot: 000913270a, test base part number 195-430wjr/lot: 913270.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 000913270a showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 4CT
• 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: 23133076
• Report Number: 1221359-2025-00383
• Device Sequence Number: 8847523
• Product Code: QYT
• UDI-Device Identifier: 00811877011729
• UDI-Public: 01008118770117291726070410000913270A
• 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,Followup
• Report Date (Section B): 12/23/2025

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: 07/04/2026
• Device Catalogue Number: 195-180
• Device Lot Number: 000913270A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 12/19/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/29/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Race: Asian