BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-01663
- Event Type
- Malfunction
- Date Received
- November 15, 2023
- Date of Event
- October 31, 2023
- Report Date
- December 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
THE CUSTOMER PROVIDED THE INFORMATION FOR TWO LOT NUMBERS BUT DID NOT CLARIFY WHICH LOT GENERATED WHICH RESULT. D4: LOT: 225711, EXP DATE: 20AUG2024, UDI: (B)(4) LOT: 202867 EXP DATE: 13FEB2024, UDI: (B)(4) INVESTIGATION RESULTS FOR LOT 225711: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225711 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: 225711, TEST BASE PART NUMBER 195-430WJR/ LOT: 223210. 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 225711 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. INVESTIGATION RESULTS FOR LOT 202867: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 202867 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: 202867, TEST BASE PART NUMBER 195-430H/ LOT: 197654. 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 202867 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. SINGLE USE; DEVICE DISCARDED.
THE CUSTOMER PROVIDED THE INFORMATION FOR TWO LOT NUMBERS BUT DID NOT CLARIFY WHICH LOT GENERATED WHICH RESULT. D4: LOT: 225711, EXP DATE: 20AUG2024, UDI: (B)(4) LOT: 202867 EXP DATE: 13FEB2024, 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.
THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL KITTED SWAB. REPEAT TESTING WAS PERFORMED TWICE ON (B)(6) 2023 AND YIELDED A NEGATIVE AND POSITIVE RESULT. ADDITIONAL TESTING WAS PERFORMED ON (B)(6) 2023 THREE (3) TIMES: AN ¿AT HOME PCR¿ TEST, A FLOWFLEX RAPID ANTIGEN TEST, AND A QUICKVIEW RAPID ANTIGEN TEST, ALL GENERATING NEGATIVE RESULTS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.
THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL KITTED SWAB. REPEAT TESTING WAS PERFORMED TWICE ON (B)(6) 2023 AND YIELDED A NEGATIVE AND POSITIVE RESULT. ADDITIONAL TESTING WAS PERFORMED ON (B)(6) 2023 THREE (3) TIMES: AN ¿AT HOME PCR¿ TEST, A FLOWFLEX RAPID ANTIGEN TEST, AND A QUICKVIEW RAPID ANTIGEN TEST, ALL GENERATING NEGATIVE RESULTS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2079507 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | UNKNOWN | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Male |