Description of Event or Problem · 0
ON (B)(6) 2025 GRIFOLS WAS NOTIFIED THAT THE NATIONAL BLOOD SERVICE ZIMBABWE IN ZIMBABWE TESTED SAMPLE ID SAMPLE ID(B)(6) ON (B)(6) 2025 USING ULTRIO ELITE ML 708074 SCREENING AND DISCRIMINATORY ASSAYS. ALL GAVE NONREACTIVE RESULTS OTHER THAN UE DHIV WHICH GAVE AN INVALID RESULT DUE TO A QNS ERROR. THE SAMPLE WAS ALSO SEROLOGY TESTED WITH THE FOLLOWING RESULTS: ANTI-HCV POSITIVE, NEGATIVE FOR HIV COMBO AND HBSAG THE FOLLOWING IS A SUMMARY OF THE ULTRIO ELITE ML 708074 TESTING COMPLETED ON (B)(6) 2025 FOR SAMPLE ID (B)(6): ULTRIO ELITE NONREACTIVE WITH AN S/CO OF 0.06, ULTRIO ELITE DHBV NONREACTIVE WITH AN S/CO OF 0.00, ULTRIO ELITE DHCV NONREACTIVE WITH AN S/CO OF 0.00, ULTRIO ELITE DHIV INVALID DUE TO QNS ERROR. THE FOLLOWING IS A SUMMARY OF THE SEROLOGY TESTING COMPLETED ON (B)(6) 2025 FOR SAMPLE ID (B)(6): ANTI-HCVII REACTIVE WITH AN S/CO 1.24, ANTI-HCVII REACTIVE WITH AN S/CO 1.22, ANTI-HCVII REACTIVE WITH AN S/CO 1.17, HIV COMBO NONREACTIVE WITH AN S/CO 0.07, HBSAG NONREACTIVE WITH AND S.CO OF 0.27. GRIFOLS IS WORKING WITH THE DISTRIBUTOR TO DETERMINE IF SAMPLE IS AVAILABLE FOR INVESTIGATIONAL TESTING IN ORDER TO COMPLETE QUANTIFICATION OF THE HCV VIRAL LOAD OF THE SAMPLE TO DETERMINE IF IT IS BELOW THE LIMIT OF DETECTION OF THE ULTRIO ELITE SCREENING AND DHCV ASSAYS. THE INVESTIGATION AT GRIFOLS IS CURRENTLY IN PROGRESS. WORKLIST REPORTS FOR THE ULTRIO ELITE RUNS AT THE CUSTOMER SITE WERE REVIEWED. ANALYSIS OF CALIBRATOR AND IC VALUES SHOWS NORMAL VALUES. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR PROCLEIX ULTRIO ELITE ML 708074 WAS PERFORMED. DHR REVIEW CONFIRMED THAT THE MASTER LOT PERFORMED AS EXPECTED AND MET ALL QC RELEASE SPECIFICITY AND SENSITIVITY CRITERIA. AN UPDATE TO THIS REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.