BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-01719
- Event Type
- Malfunction
- Date Received
- December 7, 2023
- Date of Event
- November 1, 2023
- Report Date
- December 18, 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
B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D4-UDI:(B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 204538 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: 204538, TEST BASE PART NUMBER 195-430H/ LOT: 200044. 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 204538 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 POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.D4/H10: UDI H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 204538 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: 204538, TEST BASE PART NUMBER 195-430H/ LOT: 200044. 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 204538 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 POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.
B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. 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 AN UNKNOWN DATE ON A NASAL KITTED SWAB. ADDITIONAL TESTING WAS PERFORMED ON THE SAME DAY VIA A FLOWFLEX RAPID ANTIGEN TEST WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO MEDICATIONS OR MEDICAL TREATMENT GIVEN. NO ADDITIONAL INFORMATION INCLUDING DELAY IN TREATMENT OR PATIENT HARM WAS PROVIDED.
THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. 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 AN UNKNOWN DATE ON A NASAL KITTED SWAB. ADDITIONAL TESTING WAS PERFORMED ON THE SAME DAY VIA A FLOWFLEX RAPID ANTIGEN TEST WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO MEDICATIONS OR MEDICAL TREATMENT GIVEN. NO ADDITIONAL INFORMATION INCLUDING DELAY IN TREATMENT OR PATIENT HARM WAS PROVIDED.
THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. 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 AN UNKNOWN DATE ON A NASAL KITTED SWAB. ADDITIONAL TESTING WAS PERFORMED ON THE SAME DAY VIA A FLOWFLEX RAPID ANTIGEN TEST WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO MEDICATIONS OR MEDICAL TREATMENT GIVEN. NO ADDITIONAL INFORMATION INCLUDING DELAY IN TREATMENT OR PATIENT HARM WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1128792 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 204538 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |