ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT
Report
- Report Number
- 3008344661-2025-00065
- Event Type
- Malfunction
- Date Received
- May 8, 2025
- Date of Event
- April 16, 2025
- Report Date
- July 9, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- LOM
- UDI-DI
- 00380740160586
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION E1 - PHONE COMPLETE ENTRY = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 01R64-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01R64-21, AND A PMA NUMBER OF P210003.
THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I HBSAG NEXT QUALITATIVE AND CONFIRMED POSITIVE ALINITY I HBSAG QUALITATIVE II CONFIRMATORY RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF ALINITY I HBSAG NEXT QUALITATIVE, LOT 67085FZ00, AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY, LOT 69143FZ00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOTS ARE PERFORMING ACCEPTABLY. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCTS AND THE LIKELY CAUSE LOTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY RECORD REVIEW OF THE LOTS DID NOT SHOW ANY NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I HBSAG NEXT QUALITATIVE, LOT 67085FZ00, AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY, LOT 69143FZ00, WAS IDENTIFIED.
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG NEXT QUALITATIVE AND ALINITY I HBSAG NEXT CONFIRMATORY RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT WAS 6.16, REPEAT RESULTS WERE 8.60 AND 0.17 S/CO. THE SAMPLE WAS REPEATED ON AN ARCHITECT ANALYZER AND THE RESULT WAS 0.33 S/CO, WHICH IS NONREACTIVE. THE SAMPLE WAS TESTED WITH THE HBSAGNX CONFIRMATORY ASSAY, AND THE RESULTS WERE C2 WAS 8.60 S/CO, C1 WAS 0.63 S/CO, %N WAS 96%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG NEXT QUALITATIVE AND ALINITY I HBSAG NEXT CONFIRMATORY RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT WAS 6.16, REPEAT RESULTS WERE 8.60 AND 0.17 S/CO. THE SAMPLE WAS REPEATED ON AN ARCHITECT ANALYZER AND THE RESULT WAS 0.33 S/CO, WHICH IS NONREACTIVE. THE SAMPLE WAS TESTED WITH THE HBSAGNX CONFIRMATORY ASSAY, AND THE RESULTS WERE C2 WAS 8.60 S/CO, C1 WAS 0.63 S/CO, %N WAS 96%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 946269 | ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT IRELAND DIAGNOSTICS DIVISION | 67085FZ00 | 00380740160586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I HBSAG NXT CONF, 01R65-22, 69143FZ00| ALNTY I HBSAG NXT CONF, 01R65-22, 69143FZ00| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |