MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported two (2) false positive results with two (2) patients with the binaxnow covid-19 ag test taken on (b)(6) 2026.The report is for test 1 with patient 1.The customer reported a false positive result with the binaxnow covid-19 ag test taken on (b)(6) 2026.A pcr test returned negative results.Although requested, no additional information including treatment or outcome was provided.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• 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: 25178059
• Report Number: 1221359-2026-00165
• Device Sequence Number: 10427495
• Product Code: QYT
• UDI-Device Identifier: 10811877011290
• UDI-Public: (01)10811877011290(17)270217(10)00996155BY
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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 Catalogue Number: 195-000
• Device Lot Number: 00996155BY
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• 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: 16 DA
• Patient Sex: Unknown