BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-00102
- Event Type
- Malfunction
- Date Received
- January 16, 2023
- Date of Event
- January 9, 2023
- Report Date
- April 5, 2023
- 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
- 003
Narratives
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 215068 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 KIT PART NUMBER 195-160/ LOT 215068 AND DEVICE PART NUMBER 195-430WJR/ LOT 212838. 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 215068 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.D4 (EXPIRATION DATE) H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE; DEVICE DISCARDED.
THE CONSUMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR ONE PATIENT AND MULTIPLE TESTS PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST FIVE (5) OF SIX (6). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. CONFIRMATION TESTING VIA UNKNOWN PCR AT A CVS PHARMACY WAS PERFORMED TWO (2) DAYS PRIOR ((B)(6) 2023) ON AN UNKNOWN SWAB AND GENERATED A NEGATIVE RESULT (THAT THE CONSUMER RECEIVED ON (B)(6) 2023). THE CONSUMER STATED THAT HE WAS SYMPTOMATIC BEGINNING ON (B)(6) 2022. HE NOTED THAT HE HAD A "RUNNY NOSE, COUGH, MUCUS DISCHARGE, AND COLD CHILLS". THE CONSUMER REPORTED THAT HE WAS PRESCRIBED PAXLOVID TABLETS TO TAKE FOR FIVE (5) DAYS AND TO QUARANTINE FOR ELEVEN (11) DAYS, BEGINNING ON (B)(6) 2022.
THE CONSUMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR ONE PATIENT AND MULTIPLE TESTS PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST FIVE (5) OF SIX (6). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. CONFIRMATION TESTING VIA UNKNOWN PCR AT A CVS PHARMACY WAS PERFORMED TWO (2) DAYS PRIOR ((B)(6) 2023) ON AN UNKNOWN SWAB AND GENERATED A NEGATIVE RESULT (THAT THE CONSUMER RECEIVED ON (B)(6) 2023). THE CONSUMER STATED THAT HE WAS SYMPTOMATIC BEGINNING ON (B)(6) 2022. HE NOTED THAT HE HAD A "RUNNY NOSE, COUGH, MUCUS DISCHARGE, AND COLD CHILLS". THE CONSUMER REPORTED THAT HE WAS PRESCRIBED PAXLOVID TABLETS TO TAKE FOR FIVE (5) DAYS AND TO QUARANTINE FOR ELEVEN (11) DAYS, BEGINNING ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1172483 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 215068 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male |