DETERMINE HIV-1/2 AG/AB COMBO 25T
Report
- Report Number
- 1221359-2025-00221
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- March 17, 2025
- Report Date
- November 6, 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
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.
ADDITIONAL INFORMATION: PATIENT WAS CONFIRMED NOT PREGNANT. NEW INFORMATION WAS PROVIDED ON PATIENT DEMOGRAPHICS, BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.
ADDITIONAL INFORMATION: D4: CUSTOMER WAS UNABLE TO CONFIRM WHICH OF THE TWO LOTS MENTIONED BELOW WERE USED ON 17MAR2025. -LN: 0000939868, EXPIRATION DATE 28SEP2026, DEVICE MFG DATE: 04DEC2024, PRIMARY UDI NUMBER: (B)(4). -LN: 0000962456, EXPIRATION DATE 28OCT2026, DEVICE MFG DATE: 23JAN2025, PRIMARY UDI NUMBER: (B)(4). LN: 0000939868 AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 0000939868, 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. LN: 0000962456 AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 0000962456, 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 THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON (B)(6) 2025 USING FINGERSTICK SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED WITH HIV 1/2 GEN 4 GEENIUS REFLEX TEST ON (B)(6) 2025 USING VENOUS SAMPLE WHICH GENERATED NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON (B)(6) 2025 USING FINGERSTICK SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED WITH HIV 1/2 GEN 4 GENIUS REFLEX TEST ON (B)(6) 2025 USING VENOUS SAMPLE WHICH GENERATED NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON (B)(6) 2025 USING FINGERSTICK SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED WITH HIV 1/2 GEN 4 GEENIUS REFLEX TEST ON (B)(6) 2025 USING VENOUS SAMPLE WHICH GENERATED NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016435 | DETERMINE HIV-1/2 AG/AB COMBO 25T | TEST, HIV DETECTION | MZF | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Female |