PROCLEIX ULTRIO ELITE ASSAY

Description of Event or Problem

ON 17JUL2025, GRIFOLS CUSTOMER CREATIVE TESTING SOLUTIONS AZ (USE) REPORTED DISCREPANCY BETWEEN UE SCREENING AND DISCRIMINATORY TESTING. TESTING WAS PERFORMED IN (B)(6) 2025 USING MASTER LOT, PROCLEIX ULTRIO ELITE, MN 9051171, LN 708157. MASTER POOL SAMPLE (B)(6) TESTED REACTIVE FOR ULTRIO ELITE. ALL SAMPLES IN THE POOL WERE NONREACTIVE FOR UE IN IDT TESTING. IDT SAMPLE (B)(6) TESTED REACTIVE FOR DHBV DISCRIMINATORY TEST. ALINITY SEROLOGY RESULTS FOR IDT SAMPLE (B)(6) WERE ANTI-HBC (X2) REACTIVE AND HBSAG NONREACTIVE. THE DONATION WAS DEFERRED. SAMPLES WERE NOT AVAILABLE FOR INVESTIGATIONAL TESTING AT GRIFOLS. THE TESTING DATA IS SUMMARIZED BELOW: ULTRIO ELITE SAMPLE ID (B)(6). S/C0 7.92 REACTIVE IDT SAMPLE (B)(6) S/C0 0.11 NONREACTIVE. DHBV DT SAMPLE (B)(6) S/C0 14.13 REACTIVE. SEROLOGY: ALINITY (DONE ON (B)(6) 2025) ANTI-HBC 2X REACTIVE HBSAG NONREACTIVE HCV NONREACTIVE HIV NONREACTIVE. NO RELATED QUALITY EVENTS WERE FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. A PREVIOUS EVENTS SEARCH DID NOT INDICATE A TREND FOR HBV SENSITIVITY ISSUES WITH ULTRIO ELITE ML 708157. THE ROOT CAUSE OF THE NONREACTIVE ULTRIO ELITE RESULT IS LIKELY LOW TITER HBV. INTERMITTENT REACTIVITY IS EXPECTED AT CONCENTRATIONS AT OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. THE SEROLOGICAL PROFILE IS CONSISTENT WITH OCCULT HBV INFECTION (OBI), WHICH IS MARKED BY LOW TO UNDETECTABLE LEVELS OF HBV DNA. NO ADDITIONAL INFORMATION IS EXPECTED, AND THIS IS THE FINAL REPORT.