Description of Event or Problem · 0
ON (B)(6) 2026, (B)(6) (CHINA) REPORTED A DONOR PLASMA SAMPLE TESTED NONREACTIVE ON ULTRIO ELITE ML 708172 AND 708892 BUT TESTED HBSAG REACTIVE ON SEROLOGY AND ON MPX ROCHE5800. ON (B)(6) 2026, A DONOR SAMPLE WAS TESTED ON ULTRIO ELITE ML 708172 WITH NONREACTIVE RESULTS. THE SAME SAMPLE TESTED REACTIVE IN POOL6 ON MPX ROCHE5800. SEROLOGY RESULTS WERE REACTIVE FOR HBSAG ON THE XINCHUANG ELISA TEST AND WANTAI ELISA TEST. ON (B)(6) 2026, THE SAME SAMPLE TUBE WAS TESTED REACTIVE ON IDT MPX ROCHE5800. ON (B)(6) 2026, A RESERVE TUBE OF THE DONOR SAMPLE WAS RETESTED TWICE ON ULTRIO ELITE ML 708892 RESULTING IN NONREACTIVE RESULTS. ON (B)(6) 2026, THE SAME SAMPLE WAS TESTED ON A LOCAL NAT SYSTEM (HOAYUAN) WITH REACTIVE RESULTS. THE LOCAL NAT SYSTEM (HOAYUAN HAD AN LOD FOR HBV FOR 95% PROBIT ANALYSIS = 1.94 IU/ML IDT) THE BLOOD DONATION WAS NOT USED. SUMMARY OF CUSTOMER TESTING: (B)(6) 2026: ULTRIO ELITE ML 708172 0.81 S/CO, NONREACTIVE. MPX ROCHE 5800, POOL6 RESULT CT 37.85, REACTIVE, SEROLOGY, XINCHUANG ELISA: 4.07 S/CO, HBSAG REACTIVE, WANTAI ELISA: 6.80 S/CO, HBSAG REACTIVE. (B)(6) 2026, MPX ROCHE 5800, IDT RESULT CT 38.5, REACTIVE. (B)(6): ULTRIO ELITE ML 708892 0.29 S/CO, NONREACTIVE 0.11 S/CO, NONREACTIVE (B)(6) 2026: HAOYUAN NAT IDT RESULT CT 40.24, REACTIVE AN INVESTIGATION IS ONGOING FOR THE DISCREPANT HBV RESULTS. REMAINING SAMPLE FROM THE DONOR WAS NOT AVAILABLE FOR INVESTIGATIONAL TESTING AT GRIFOLS NOR WAS THERE ANY ADDITIONAL SAMPLE AVAILABLE TO PERFORM QUANTITATIVE TESTING AT THE CUSTOMER SITE. NO RELATED QUALITY EVENTS WERE FOUND FOR THE TWO LOTS/BATCHES OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. A PREVIOUS EVENTS SEARCH DID NOT INDICATE A TREND FOR HBV SENSITIVITY ISSUES WITH PROCLEIX ULTRIO ELITE ML 708172 OR ML 708892. ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FINAL REPORT.