Description of Event or Problem · 1
ON (B)(6) 2021, GRIFOLS CUSTOMER QUALTEX LABS ((B)(6) REPORTED A PROCLEIX ULTRIO ELITE ASSAY NONREACTIVE, HIV SEROLOGY POSITIVE RESULT IN A SERUM SAMPLE. PLASMA FROM THE SAME DONOR WAS RETESTED IN DUPLICATE WITH THE PROCLEIX ULTRIO ELITE ASSAY AND WAS REACTIVE IN BOTH REPLICATES. THE PLASMA SAMPLE WAS ALSO TESTED WITH THE PROCLEIX HIV DISCRIMINATORY ASSAY (DHIV) AND WAS HIV REACTIVE. THE CUSTOMER RELEASED RESULTS AS ULTRIO ELITE REACTIVE, DHIV REACTIVE AND THE SAMPLE WAS DISCARDED. NO VOLUME REMAINS FOR INVESTIGATION AND NO DONOR HISTORY WAS AVAILABLE. A PREVIOUS EVENTS SEARCH SHOWED ONE OTHER COMPLAINT (B)(4) FOR ULTRIO ELITE FALSE NEGATIVE OVER THE PRIOR YEAR. THE ROOT CAUSE WAS DETERMINED TO BE LOW TITER SAMPLE. THE REAGENT QC RELEASE DATA WAS REVIEWED AND THERE WERE NO INDICATIONS OF A PROBLEM WITH HIV SENSITIVITY. MASTER LOT 703154 PASSED ALL SENSITIVITY SPECIFICATIONS FOR HIV-1 AND HIV-2, IN ADDITION TO ALL OTHER ANALYTES AND SPECIFICATIONS. WITHOUT REMAINING SAMPLE VOLUME FOR INVESTIGATION, ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE PREVIOUS EVENTS SEARCH AND THE REVIEW OF THE MASTER LOT RELEASE DATA, THE MOST LIKELY ROOT CAUSE IS LOW TITER HIV. NO FURTHER INFORMATION IS EXPECTED, THIS IS CONSIDERED THE FINAL REPORT.