DETERMINE HIV-1/2 AG/AB COMBO 25T
Report
- Report Number
- 1221359-2025-00054
- Event Type
- Malfunction
- Date Received
- February 18, 2025
- Date of Event
- February 12, 2025
- Report Date
- October 7, 2025
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- MZF
- PMA / PMN Number
- BP120037
- Removal / Correction Number
- 1221359-07/31/2025-002-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPON RECEIVING PATIENT DEMOGRAPHIC INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT. ADDITIONAL INFORMATION: A3A ¿ SEX, D4 - CATALOG #, D4 - LOT #, D4 - EXPIRATION DATE, D4 - PRIMARY UDI NUMBER, H4 - DEVICE MFG DATE. B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATES WERE NOT PROVIDED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 824739 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: 824739, TEST BASE PART NUMBER 10732998 / LOT: 820232. 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 824739 SHOWED THAT THE COMPLAINT RATE IS 0.00872%. 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.
B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATES WERE NOT PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
UPON RECEIVING PATIENT DEMOGRAPHIC INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT. B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATES WERE NOT PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
ADDITIONAL INFORMATION: B3 - DATE OF EVENT, B5 - DESCRIBE EVENT OR PROBLEM, H6 - MEDICAL DEVICE PROBLEM CODE. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 824739 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: 824739, TEST BASE PART NUMBER 10732998 / LOT: 820232. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 824739 SHOWED THAT THE COMPLAINT RATE IS (B)(4), RESPECTIVELY. AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 824739, THE ROOT CAUSE OF THE RESULTS WAS DUE TO A SUBCOMPONENT USED IN THE MANUFACTURE OF DETERMINE HIV-1/2 AG/AG COMBO. THE ISSUE HAS BEEN ISOLATED TO SPECIFIC LOTS OF THE SUBCOMPONENT, WHICH WERE USED TO MANUFACTURE SPECIFIC TEST KIT LOTS. THE NECESSARY ACTIONS TO PREVENT RECURRENCE HAVE BEEN TAKEN, AND THE CORRECTION OF PRODUCT IN THE FIELD WAS CONDUCTED.
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST ON UNKNOWN DATES. NO INFORMATION ON CONFIRMATION TESTING WAS PROVIDED.
THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST ON UNKNOWN DATES. NO INFORMATION ON CONFIRMATION TESTING WAS PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT DETAILS ABOUT TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST ON UNKNOWN DATES. NO INFORMATION ON CONFIRMATION TESTING WAS PROVIDED.
THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON (B)(6) 2025 WITH A WHOLE BLOOD SAMPLE. THE CUSTOMER INDICATED THAT THE PATIENT INITIALLY TESTED POSITIVE FOR HIV ABY WITH THE DETERMINE HIV TEST KIT WITH A WHOLE BLOOD SAMPLE. THE PATIENT WAS RETESTED ON SAME DAY WITH THE DETERMINE HIV TEST KIT WITH A WHOLE BLOOD SAMPLE, WHICH RESULTED IN A NEGATIVE RESULT. THE PATIENT HAD NO SYMPTOMS AND HAD NO EXPOSURE PATHWAYS. THE CONFIRMATORY TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2572773 | DETERMINE HIV-1/2 AG/AB COMBO 25T | TEST, HIV DETECTION | MZF | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 824739 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |