DETERMINE HIV-1/2 AG/AB COMBO 25T
Report
- Report Number
- 1221359-2025-00239
- Event Type
- Malfunction
- Date Received
- May 15, 2025
- Date of Event
- April 17, 2025
- Report Date
- October 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
NEW INFORMATION WAS PROVIDED ON PATIENT DEMOGRAPHICS, AND BASED UPON THIS NEW INFORMATION THIS IS NO LONGER A REPORTABLE EVENT. B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.
B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED.THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.
ADDITIONAL INFO, B3, B5, H7,H9. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000939868 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 0000939868 AND DEVICE PART NUMBER 10732998 LOT 944760. 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 0000939868 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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.
THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT, SAMPLE TYPE (FINGERSTICK) PERFORMED ON (B)(6) 2025, RESPECTIVELY. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED A POSITIVE RESULT ON THE DETERMINE HIV-1/2 AG/AB COMBO TEST ON (B)(6) 2025. A CONFIRMATORY TEST (HIV 1/2 4TH GEN REFLEX GEENIUS) WAS PERFORMED ON AN UNKNOWN DATE , AND GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1896069 | DETERMINE HIV-1/2 AG/AB COMBO 25T | TEST, HIV DETECTION | MZF | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 0000939868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male |