BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-01749
- Event Type
- Malfunction
- Date Received
- December 14, 2023
- Date of Event
- November 27, 2023
- Report Date
- February 8, 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
FDA UDI (B)(4). THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
FDA UDI (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 227417 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 227417 AND DEVICE PART NUMBER 195-430H/ LOT 223559. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 227417 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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.
FDA UDI (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 227417 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 227417 AND DEVICE PART NUMBER 195-430H/ LOT 223559. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 227417 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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. H2 - DEVICE EVALUATION / ADDITIONAL INFORMATION H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
THE CONSUMER REPORTED THREE FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER¿S REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. CONSUMER PERFORMED A FLOWFLEX ANTIGEN SELF-TEST ON AN UNKNOWN DATE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC WITH CHILLS, FEELING HOT, NAUSEA, AND AN ACHING HEAD. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CONSUMER REPORTED THREE FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER¿S REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. CONSUMER PERFORMED A FLOWFLEX ANTIGEN SELF-TEST ON AN UNKNOWN DATE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC WITH CHILLS, FEELING HOT, NAUSEA, AND AN ACHING HEAD. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CONSUMER REPORTED THREE FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER¿S REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. CONSUMER PERFORMED A FLOWFLEX ANTIGEN SELF-TEST ON AN UNKNOWN DATE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC WITH CHILLS, FEELING HOT, NAUSEA, AND AN ACHING HEAD. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1769974 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 227417 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |