BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-01668
- Event Type
- Malfunction
- Date Received
- November 17, 2023
- Date of Event
- November 13, 2023
- Report Date
- January 9, 2024
- 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
D4: UDI: (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.PLEASE SEE CORRECTION TO H6: MEDICAL DEVICE PROBLEM CODE H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
D4: UDI: (B)(4) THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. SINGLE USE; DEVICE DISCARDED.
D4: UDI: (B)(4), TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 221368 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 221368, TEST BASE PART NUMBER 195-430H / LOT 217320. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 221368 SHOWED THAT THE COMPLAINT RATE IS (B)(4) RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 13NOV2023 USING TESTS FROM THE SAME LOT. THE CONSUMER STATED THE FIRST TEST GENERATED A POSITIVE RESULT AND THE SECOND TEST GENERATED A NEGATIVE RESULT. NO OTHER TESTING WAS PERFORMED. THE CONSUMER WAS ASYMPTOMATIC AND CONFIRMED THERE WAS NO DELAY OR IMPACT TO TREATMENT AND NO HARM DUE TO THE TEST RESULT.
THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 USING TESTS FROM THE SAME LOT. THE CONSUMER STATED THE FIRST TEST GENERATED A POSITIVE RESULT AND THE SECOND TEST GENERATED A NEGATIVE RESULT. NO OTHER TESTING WAS PERFORMED. THE CONSUMER WAS ASYMPTOMATIC AND CONFIRMED THERE WAS NO DELAY OR IMPACT TO TREATMENT AND NO HARM DUE TO THE TEST RESULT.
THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 USING TESTS FROM THE SAME LOT. THE CONSUMER STATED THE FIRST TEST GENERATED A POSITIVE RESULT AND THE SECOND TEST GENERATED A NEGATIVE RESULT. NO OTHER TESTING WAS PERFORMED. THE CONSUMER WAS ASYMPTOMATIC AND CONFIRMED THERE WAS NO DELAY OR IMPACT TO TREATMENT AND NO HARM DUE TO THE TEST RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1926031 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 221368 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female |