ALINITY I ANTI-HCV REAGENT KIT
Report
- Report Number
- 3002809144-2025-00385
- Event Type
- Malfunction
- Date Received
- December 5, 2025
- Date of Event
- November 11, 2025
- Report Date
- February 9, 2026
- Manufacturer
- ABBOTT GMBH
- Product Code
- MZO
- UDI-DI
- 00380740169206
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P06, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P05, AND A PMA NUMBER OF P050042.
THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT 76260BE00 PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HCV ASSAY DID NOT IDENTIFY ANY RELATED TRENDS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCE OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE LOT PERFORMS AS EXPECTED. TESTING INCLUDED THE ZEPTOMETRIX HCV SEROCONVERSION PANEL (HCV 9045). THE RESULTS WERE CONSISTENT WITH THE ANTI-HCV RESULTS PROVIDED BY ZEPTOMETRIX, CONFIRMING THE EXPECTED PERFORMANCE OF THE LOT 76260BE00. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. RETURN SAMPLE TESTING WAS COMPLETED USING A RETAINED REAGENT KIT OF LOT NUMBER 76260BE00 AND A NON-REACTIVE RESULT (0.52 S/CO) WAS OBTAINED. SUPPLEMENTAL TESTING WAS PERFORMED WITH ALINITY I ANTI-HCV NEXT AND A REACTIVE RESULT (47.53 S/CO) WAS OBTAINED. FURTHER, THE SAMPLE WAS TESTED WITH INNO-LIA HCV SCORE AND MIKROGEN RECOMLINE HCV IGG. NO BANDS WERE DETECTED WITH INNO-LIA HCV SCORE, THE RESULT IS NEGATIVE. BANDS OF CORE 1 (+), CORE 2 (+/-), HELICASE (+/-), NS3 (+) AND NS5 (+/-) WERE DETECTED WITH MIKROGEN RECOMLINE HCV IGG AND THE RESULT IS POSITIVE. BASED ON THE TESTING RESULTS, THE FINAL INTERPRETATION IS INCONCLUSIVE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I ANTI-HCV REAGENT, LOT NUMBER 76260BE00.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS WHEN COMPARED TO AN ALINITY I ANTI-HCV NEXT RESULT FOR A 55-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6), INITIAL RESULT, ON (B)(6) 2025, WAS 0.48, REPEAT RESULTS WERE 0.45, 0.52, AND 0.47 S/CO. THE SAMPLE WAS TESTED WITH THE ALINITY I ANTI-HCV NEXT ASSAY, AND THE RESULTS WERE 46.90, 48.63, AND 48.42 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS WHEN COMPARED TO AN ALINITY I ANTI-HCV NEXT RESULT FOR A 55-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6), INITIAL RESULT, ON (B)(6) 2025, WAS 0.48, REPEAT RESULTS WERE 0.45, 0.52, AND 0.47 S/CO. THE SAMPLE WAS TESTED WITH THE ALINITY I ANTI-HCV NEXT ASSAY, AND THE RESULTS WERE 46.90, 48.63, AND 48.42 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1990975 | ALINITY I ANTI-HCV REAGENT KIT | ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS | MZO | ABBOTT GMBH | 76260BE00 | 00380740169206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | ALN I ANTIHCVNX RGT 200,06T79-22,78164BE00| ALNTY I PROCESSING MODU,03R65-01, (B)(6) |