BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-00492
- Event Type
- Malfunction
- Date Received
- March 14, 2023
- Date of Event
- February 26, 2023
- Report Date
- May 11, 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
D4: THE CONSUMER REPORTED TWO LOT NUMBERS 217335 AND 223601 FOR TESTS PERFORMED ON 26FEB2023: LOT NUMBER 217335 GENERATED A NEGATIVE RESULT AND A POSITIVE RESULT AND LOT NUMBER 223601 GENERATED A POSITIVE RESULT. SINCE WE ARE NOT CERTAIN OF WHICH TEST PROVIDED THE CORRECT RESULT SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NO. 217335 EXPIRATION DATE: 05JUL2024 INFORMATION FOR LOT NUMBER 223601 EXPIRATION DATE: 07AUG2024 INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M185870 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 217335 / LOT 223601 AND DEVICE PART NUMBER 195-430H / LOT 215331 AND 195-430WL / LOT 221436. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE AND FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 217335 SHOWED THAT THE COMPLAINT RATE IS (B)(4)% RESPECTIVELY. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 223601 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 POSSIBLY BE RELATED TO ISSUES INCLUDING THE INTERPRETATION OF THE RESULT OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE DEVICE: DEVICE DISCARDED.
D4: THE CONSUMER REPORTED TWO LOT NUMBERS 217335 AND 223601 FOR TESTS PERFORMED ON (B)(6) 2023: LOT NUMBER 217335 GENERATED A NEGATIVE RESULT AND A POSITIVE RESULT AND LOT NUMBER 223601 GENERATED A POSITIVE RESULT. SINCE WE ARE NOT CERTAIN OF WHICH TEST PROVIDED THE CORRECT RESULT SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NO. 217335. EXPIRATION DATE: 05JUL2024 . INFORMATION FOR LOT NUMBER 223601. EXPIRATION DATE: 07AUG2024. INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 217335 AND 223601 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 217335 / LOT 223601 AND DEVICE PART NUMBER 195-430H / LOT 215331 AND 195-430WL / LOT 221436. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE AND FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 217335 SHOWED THAT THE COMPLAINT RATE IS (B)(4) RESPECTIVELY. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 223601 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 POSSIBLY BE RELATED TO ISSUES INCLUDING THE INTERPRETATION OF THE RESULT OR THE SPECIFIC PATIENT SAMPLE.H10: UPDATED THE INVESTIGATION RETAINED KIT LOT NUMBER M185870 TO LOT NUMBERS 217335 AND 223601. H3 OTHER TEXT : SINGLE USE DEVICE: DEVICE DISCARDED.
THE CONSUMER REPORTED TWO LOT NUMBERS 217335 AND 223601 FOR TESTS PERFORMED ON (B)(6) 2023: LOT NUMBER 217335 GENERATED A NEGATIVE RESULT AND A POSITIVE RESULT AND LOT NUMBER 223601 GENERATED A POSITIVE RESULT. SINCE WE ARE NOT CERTAIN OF WHICH TEST PROVIDED THE CORRECT RESULT SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NO. 217335. EXPIRATION DATE: 05JUL2024. INFORMATION FOR LOT NUMBER 223601. EXPIRATION DATE: 07AUG2024. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE DEVICE: DEVICE DISCARDED.
THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2023. THE CONSUMER CONFIRMED THAT HE TESTED THREE TIMES ON (B)(6) 2023. PER THE CONSUMER, THE FIRST TEST GENERATED A NEGATIVE RESULT, THE SECOND TEST AND THIRD TEST GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2023. THE CONSUMER CONFIRMED THAT HE TESTED THREE TIMES ON (B)(6) 2023. PER THE CONSUMER, THE FIRST TEST GENERATED A NEGATIVE RESULT, THE SECOND TEST AND THIRD TEST GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2023. THE CONSUMER CONFIRMED THAT HE TESTED THREE TIMES ON (B)(6) 2023. PER THE CONSUMER, THE FIRST TEST GENERATED A NEGATIVE RESULT, THE SECOND TEST AND THIRD TEST GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 700323 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male |