ALINITY I ANTI-HCV REAGENT KIT
Report
- Report Number
- 3002809144-2025-00328
- Event Type
- Malfunction
- Date Received
- October 16, 2025
- Date of Event
- November 1, 2019
- Report Date
- December 22, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- MZO
- UDI-DI
- 00380740169206
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HCV ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW DOES NOT IDENTIFY ANY RELATED NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HCV REAGENT WAS IDENTIFIED.
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P06, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P05, WITH PMA NUMBER P050042. 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.
A LITERATURE ARTICLE BY WAJNAT A. TOUNSI, ET.AL., ¿THE ¿GREY ZONE¿ IN BLOOD DONOR SCREENING: A RETROSPECTIVE STUDY AND PROPOSAL FOR DONOR RE-ENTRY¿, DIAGNOSTICS 2025, 15, 2261. MDPI AG, DOCUMENTED FALSE NONREACTIVE ANTI-HBC, HBSAG, ANTI-HCV, HTLV, AND SYPHILIS, FOR DONOR SAMPLES. THE DONOR BLOOD SCREENING WAS PERFORMED ON THE ARCHITECT SYSTEM AND, LATER IN THE STUDY, THE ALINITY I SYSTEM. A RETROACTIVE STUDY WAS PERFORMED FOR DONOR SAMPLES COLLECTED BETWEEN NOVEMBER 2019 AND NOVEMBER 2024. DONOR SAMPLE RESULTS FOR HBSAG, ANTI-HBC, HCV ANTIBODY, HIV ANTIGEN/ANTIBODY COMBO, HTLV ANTIBODY, AND SYPHILIS ANTIBODY WERE COLLECTED FOR INITIAL SCREENING, REPEAT 1 AND 2 TESTS, AS WELL AS NAT RESULTS FOR HIV, HCV, AND HBV. A TOTAL OF 48,241 BLOOD DONATIONS, WITH 38,562 UNIQUE DONORS, WERE TESTED. INITIAL SCREENING RESULTS WERE INTERPRETED AS REACTIVE (S/CO = 1.0), GREY ZONE (0.90 = S/CO < 1.0), OR NONREACTIVE (S/CO < 0.90) WITH REPEAT TESTING PERFORMED FOR SAMPLES WITH AN INTERPRETATION OF GREY ZONE OR REACTIVE. THE FOLLOWING INFORMATION WAS PROVIDED: 76 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HBC, OF WHICH 24 REPEATED AS REACTIVE. 28 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HBSAG, OF WHICH 8 REPEATED AS REACTIVE. 39 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HCV, OF WHICH 11 REPEATED AS REACTIVE. 20 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HTLV, OF WHICH 3 REPEATED AS REACTIVE. 36 DONOR SAMPLES HAD INITIAL RESULT IN GREY ZONE FOR SYPHILIS, OF WHICH 11 REPEATED REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
A LITERATURE ARTICLE BY WAJNAT A. TOUNSI, ET.AL., ¿THE ¿GREY ZONE¿ IN BLOOD DONOR SCREENING: A RETROSPECTIVE STUDY AND PROPOSAL FOR DONOR RE-ENTRY¿, DIAGNOSTICS 2025, 15, 2261. MDPI AG, DOCUMENTED FALSE NONREACTIVE ANTI-HBC, HBSAG, ANTI-HCV, HTLV, AND SYPHILIS, FOR DONOR SAMPLES. THE DONOR BLOOD SCREENING WAS PERFORMED ON THE ARCHITECT SYSTEM AND, LATER IN THE STUDY, THE ALINITY I SYSTEM. A RETROACTIVE STUDY WAS PERFORMED FOR DONOR SAMPLES COLLECTED BETWEEN NOVEMBER 2019 AND NOVEMBER 2024. DONOR SAMPLE RESULTS FOR HBSAG, ANTI-HBC, HCV ANTIBODY, HIV ANTIGEN/ANTIBODY COMBO, HTLV ANTIBODY, AND SYPHILIS ANTIBODY WERE COLLECTED FOR INITIAL SCREENING, REPEAT 1 AND 2 TESTS, AS WELL AS NAT RESULTS FOR HIV, HCV, AND HBV. A TOTAL OF 48,241 BLOOD DONATIONS, WITH 38,562 UNIQUE DONORS, WERE TESTED. INITIAL SCREENING RESULTS WERE INTERPRETED AS REACTIVE (S/CO = 1.0), GREY ZONE (0.90 = S/CO < 1.0), OR NONREACTIVE (S/CO < 0.90) WITH REPEAT TESTING PERFORMED FOR SAMPLES WITH AN INTERPRETATION OF GREY ZONE OR REACTIVE. THE FOLLOWING INFORMATION WAS PROVIDED: 76 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HBC, OF WHICH 24 REPEATED AS REACTIVE. 28 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HBSAG, OF WHICH 8 REPEATED AS REACTIVE. 39 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HCV, OF WHICH 11 REPEATED AS REACTIVE. 20 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HTLV, OF WHICH 3 REPEATED AS REACTIVE. 36 DONOR SAMPLES HAD INITIAL RESULT IN GREY ZONE FOR SYPHILIS, OF WHICH 11 REPEATED REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2098513 | ALINITY I ANTI-HCV REAGENT KIT | ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS | MZO | ABBOTT GMBH | 00380740169206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11 |