ALINITY I HIV AG/AB COMBO REAGENT KIT
Report
- Report Number
- 3002809144-2025-00275
- Event Type
- Malfunction
- Date Received
- August 27, 2025
- Date of Event
- August 8, 2025
- Report Date
- October 16, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- MZF
- UDI-DI
- 00380740121785
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P07-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P07-21 / 31, WITH 510K/PMA/BLA NUMBER P090080. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING OF RETAINED REAGENT KIT. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE WITHOUT INDICATIONS OF ANY ADDITIONAL ISSUES. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 72378BE00. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HIV AG/AB COMBO ASSAY (LIST NUMBER 08P07) DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 72378BE00 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER¿S ISSUE. ADDITIONALLY, IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF COMPLAINT LOT 72378BE00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. FURTHERMORE, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO THE RESULTS PROVIDED BY ZEPTOMETRIX AND THE REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I HIV AG/AB COMBO REAGENT, LOT NUMBER 72378BE00.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 44-YEAR-OLD MALE PATIENT. THIS RESULT WAS INCONSISTENT WITH THE POSITIVE WESTERN BLOT METHOD AND PRIOR RAPID TEST RESULT. THE FOLLOWING DATA WAS PROVIDED: ALINITY I HIV AG/AB COMBO RESULT (LOT#72378BE00) = 0.13 S/CO (NONREACTIVE) WESTERN BLOT RESULT = POSITIVE (PRESENCE OF BANDS: GP160, GP120, P66, P51, GP41, P39, P24) PRIOR RESULT (RAPID METHOD) = POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 44-YEAR-OLD MALE PATIENT. THIS RESULT WAS INCONSISTENT WITH THE POSITIVE WESTERN BLOT METHOD AND PRIOR RAPID TEST RESULT. THE FOLLOWING DATA WAS PROVIDED: ALINITY I HIV AG/AB COMBO RESULT (LOT#72378BE00) = 0.13 S/CO (NONREACTIVE). WESTERN BLOT RESULT = POSITIVE (PRESENCE OF BANDS: GP160, GP120, P66, P51, GP41, P39, P24) PRIOR RESULT (RAPID METHOD) = POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1498312 | ALINITY I HIV AG/AB COMBO REAGENT KIT | TEST, HIV DETECTION | MZF | ABBOTT GMBH | 72378BE00 | 00380740121785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male | ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6). |