BINAXNOW COVID-19 ANTIGEN SELF-TEST
Report
- Report Number
- 1221359-2022-00397
- Event Type
- Malfunction
- Date Received
- January 21, 2022
- Date of Event
- December 25, 2021
- Report Date
- June 2, 2022
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QKP
- UDI-DI
- 00811877011408
- PMA / PMN Number
- EUA210264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED. RELATED REPORT: 1221359-2022-00398.
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 159993 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 159993 , TEST BASE PART NUMBER 195-430H / LOT 150321. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 159993 SHOWED THAT THE COMPLAINT RATE IS (B)(4) (2/314808). 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. REFERENCE MFR. REPORTS: 1221359-2022-00397 THROUGH 1221359-2022-00398.
THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED. RELATED REPORT: 1221359-2022-00398.
THE CONSUMER REPORTED A TWO FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST USING NASAL SWAB SAMPLES. THE CONSUMER PERFORMED A BINAXNOW ANTIGEN SELF TEST ON THE (B)(6) 2021 AT 10:00AM WHICH GENERATED A POSITIVE RESULT. CONFIRMATION PCR TESTING WAS PERFORMED ON (B)(6) 2021 AT 1:00PM USING AN UNKNOWN SAMPLE TYPE, WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER PERFORMED A SECOND BINAXNOW ANTIGEN SELF TEST ON (B)(6) 2021 AT 1:00PM WHICH GENERATED A POSITIVE RESULT. THE CONSUMER SCHEDULED AN ADDITIONAL CONFIRMATION PCR TEST WITH HIS HEALTHCARE PROVIDER ON (B)(6) 2021. AT THE TIME THAT THIS EVENT WAS REPORTED TO TECHNICAL SERVICES (TS) THE RESULTS WERE NOT AVAILABLE. NO ADVERSE HEALTH EFFECTS WERE REPORTED. THIS MANUFACTURER REPORT ADDRESSES FALSE POSITIVE RESULT 1 OF 2.
THE CONSUMER REPORTED A TWO FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST USING NASAL SWAB SAMPLES. THE CONSUMER PERFORMED A BINAXNOW ANTIGEN SELF TEST ON THE (B)(6) 2021 AT 10:00AM WHICH GENERATED A POSITIVE RESULT. CONFIRMATION PCR TESTING WAS PERFORMED ON (B)(6) 2021 AT 1:00PM USING AN UNKNOWN SAMPLE TYPE, WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER PERFORMED A SECOND BINAXNOW ANTIGEN SELF TEST ON (B)(6) 2021 AT 1:00PM WHICH GENERATED A POSITIVE RESULT. THE CONSUMER SCHEDULED AN ADDITIONAL CONFIRMATION PCR TEST WITH HIS HEALTHCARE PROVIDER ON (B)(6) 2021. AT THE TIME THAT THIS EVENT WAS REPORTED TO TECHNICAL SERVICES (TS) THE RESULTS WERE NOT AVAILABLE. NO ADVERSE HEALTH EFFECTS WERE REPORTED. THIS MANUFACTURER REPORT ADDRESSES FALSE POSITIVE RESULT 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729966 | BINAXNOW COVID-19 ANTIGEN SELF-TEST | LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 159993 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |