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 Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported a false negative result with the binaxnow covid-19 ag self test performed on an unknown date with a nasal sample.Additional testing (brand unknown) was performed with an unknown sample type and generated positive results.The consumer reported calling 911 the following day due to feeling weak and dehydrated, and were positive for covid-19.The consumer relayed that they are perfectly fine now.No additional information on treatment was provided.
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the exact event date was not provided.The investigation remains in progress.A supplemental report will be provided after completion.
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the exact event date was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 000784573 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: 000784573d, device part number 195-430wl/ lot: 784573.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 784573 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue, however it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.
Event or Problem Description
The consumer reported a false negative result with the binaxnow covid-19 ag self test performed on an unknown date with a nasal sample.Additional testing (brand unknown) was performed with an unknown sample type and generated positive results.The consumer reported calling 911 the following day due to feeling weak and dehydrated and were positive for covid-19.The consumer relayed that they are perfectly fine now.No additional information on treatment was provided.

• 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: 22064100
• Report Number: 1221359-2025-00243
• Device Sequence Number: 7639044
• Product Code: QYT
• UDI-Device Identifier: 00811877011729
• UDI-Public: 01008118770117291725071210000784573D
• 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): 05/28/2025

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: 07/12/2025
• Device Catalogue Number: 195-180
• Device Lot Number: 000784573D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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: Male