BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2025-00075
- Event Type
- Malfunction
- Date Received
- March 4, 2025
- Date of Event
- February 17, 2025
- Report Date
- May 22, 2025
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QKP
- UDI-DI
- 00811877011408
- PMA / PMN Number
- K243518
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000905503 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 195-160/ LOT 0000905503, TEST BASE PART NUMBER 195-430WL/ LOT 905503. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
CORRECTION: G4 - PMA/510(K) #. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000905503 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 195-160/ LOT 0000905503, TEST BASE PART NUMBER 195-430WL/ LOT 905503. 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 0000905503 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 HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.
THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST FOR MULTIPLE TESTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FIVE (5). THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2025. CONFIRMATION PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED ON (B)(6) 2025 WITH AN UNKNOWN SAMPLE TYPE AND GENERATED POSITIVE RESULTS. ADDITIONAL TESTING WAS PERFORMED WITH AN UNKNOWN BRAND ON AN UNKNOWN DATE AND GENERATED NEGATIVE RESULTS. THE CONSUMER REPORTED BEING SYMPTOMATIC WITH MULTIPLE SYMPTOMS. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST FOR MULTIPLE TESTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FIVE (5). THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2025. CONFIRMATION PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED ON (B)(6) 2025 WITH AN UNKNOWN SAMPLE TYPE AND GENERATED POSITIVE RESULTS. ADDITIONAL TESTING WAS PERFORMED WITH AN UNKNOWN BRAND ON AN UNKNOWN DATE AND GENERATED NEGATIVE RESULTS. THE CONSUMER REPORTED BEING SYMPTOMATIC WITH MULTIPLE SYMPTOMS. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST FOR MULTIPLE TESTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FIVE (5). THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2025. CONFIRMATION PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED ON (B)(6) 2025 WITH AN UNKNOWN SAMPLE TYPE AND GENERATED POSITIVE RESULTS. ADDITIONAL TESTING WAS PERFORMED WITH AN UNKNOWN BRAND ON AN UNKNOWN DATE AND GENERATED NEGATIVE RESULTS. THE CONSUMER REPORTED BEING SYMPTOMATIC WITH MULTIPLE SYMPTOMS. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472882 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 0000905503 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male |