DETERMINE HIV-1/2 AG/AB COMBO 25T
Report
- Report Number
- 1221359-2025-00387
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- September 8, 2025
- Report Date
- November 21, 2025
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- MZF
- PMA / PMN Number
- BP120037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.
CORRECTIONS: D4 - LOT #. D4 - EXPIRATION DATE. D4 - PRIMARY UDI NUMBER. H4 - DEVICE MFG DATE. THE INITIAL TEST (POSITIVE RESULT) WAS FROM LOT NUMBER 0000993124, THE SECOND TEST (NEGATIVE RESULT) WAS FROM A DIFFERENT, UNKNOWN LOT NUMBER. TEST #1 - POSITIVE RESULT. D4 - LOT #: 0000993124. D4 - EXPIRATION DATE: 1/28/2027. D4 - PRIMARY UDI NUMBER: (B)(4). H4 - DEVICE MFG DATE: 4/23/2025. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000993124 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 7D2648 / LOT 0000993124, TEST BASE PART NUMBER DEVICE PART NUMBER 10732998 / LOT 992853. 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 0000993124 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 BEEN RELATED TO THE SPECIFIC PATIENT SAMPLES. TEST #2 - NEGATIVE RESULT. D4 - LOT #: UNKNOWN. D4 - EXPIRATION DATE: NI. D4 - PRIMARY UDI NUMBER: UNKNOWN. H4 - DEVICE MFG DATE: NI. THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.
THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO FOR TWO (2) PATIENTS (AGE RANGING FROM 18-22 YEARS OLD) PERFORMED ON (B)(6) 2025. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF TWO (2). THE PATIENT INITIALLY TESTED POSITIVE WITH THE DETERMINE HIV 1/2 AG/AB COMBO. A REPEAT TEST WAS PERFORMED WITH ANOTHER DETERMINE HIV 1/2 AG/AB COMBO WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT NO ADDITIONAL OR CONFIRMATION TESTING WAS PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO FOR TWO (2) PATIENTS (AGE RANGING FROM 18-22 YEARS OLD) PERFORMED ON (B)(6) 2025. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF TWO (2). THE PATIENT INITIALLY TESTED POSITIVE WITH THE DETERMINE HIV 1/2 AG/AB COMBO. A REPEAT TEST WAS PERFORMED WITH ANOTHER DETERMINE HIV 1/2 AG/AB COMBO WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT NO ADDITIONAL OR CONFIRMATION TESTING WAS PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2393697 | DETERMINE HIV-1/2 AG/AB COMBO 25T | TEST, HIV DETECTION | MZF | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |