BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2025-00417
- Event Type
- Malfunction
- Date Received
- October 6, 2025
- Date of Event
- September 15, 2025
- Report Date
- December 4, 2025
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QYT
- PMA / PMN Number
- K243518
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.
CORRECTION: H6 - TYPE OF INVESTIGATION CODES. INVESTIGATION SUMMARY: THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.
INVESTIGATION SUMMARY: THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.
THE CONSUMER REPORTED FALSE NEGATIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. CONFIRMATION TESTING WAS PERFORMED AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THEY WERE SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
THE CONSUMER REPORTED A FALSE NEGATIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. THE CONSUMER VISITED AN URGENT CARE FACILITY ON (B)(6) 2025 WHERE CONFIRMATION TESTING (PLATFORM UNKNOWN) WAS PERFORMED AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THEY WERE SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
THE CONSUMER REPORTED A FALSE NEGATIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. THE CONSUMER VISITED AN URGENT CARE FACILITY ON (B)(6) 2025 WHERE CONFIRMATION TESTING (PLATFORM UNKNOWN) WAS PERFORMED AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THEY WERE SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2309424 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QYT | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |