FDA Adverse Event
Malfunction
Summary report: N
BINAXNOW COVID-19 AG SELF TEST 2CT
MDR report key: 25178216
·
Received May 14, 2026
Report
- Report Number
- 1221359-2026-00172
- Event Type
- Malfunction
- Date Received
- May 14, 2026
- Date of Event
- May 11, 2026
- Report Date
- May 14, 2026
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QYT
- UDI-DI
- 00811877011408
- PMA / PMN Number
- K243518
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.
Description of Event or Problem · 0
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST TAKEN ON (B)(6) 2026. NO CONFIRMATORY TEST WAS TAKEN AS THE CONSUMER DID NOT WANT TO SEEK CONSULTATION WITH A HEALTHCARE PROVIDER. THE CONSUMER EXPERIENCED LOSS OF TASTE, COLD, HEADACHE, AND A SORE THROAT AT THE TIME OF TESTING. NO NEGATIVE PATIENT IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265580 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QYT | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 000916289A | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |