ALINITY S ANTI-HBC REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY S ANTI-HBC RESULT GENERATED ON THE ALINITY S SYSTEM FOR ONE DONOR SAMPLE. THERE WAS NO PATIENT IMPACT DUE TO THE INITIAL NAT TESTING OBTAINED A POSITIVE RESULT WHICH TRIGGERED FOR A SECOND SAMPLE TO BE DRAWN. THE FOLLOWING DATA WAS PROVIDED: (B)(6): (B)(6) 2026: INITIAL ALINITY S ANTI-HBC RESULT = (B)(6); REPEAT RESULTS IN DUPLICATE = (B)(6) S/CO (THE CUSTOMER RE-CENTRIFUGED THE SAMPLE AND PIPETTED SERUM IN ANOTHER TUBE (SECOND TUBE) FOR THE DUPLICATE TESTING) (B)(6) 2026: NEW SAMPLE: INITIAL RESULT (B)(6); REPEAT RESULTS IN DUPLICATE = (B)(6) (THESE RESULTS WERE RELEASED FROM THE LABORATORY) ORIGINAL NAT TESTING WAS PERFORMED ON ORIGINAL SAMPLE AND GENERATED A POSITIVE RESULT. THE CUSTOMER REPEATED THE SAMPLE FROM (B)(6) 2026 AND STILL GENERATED NONREACTIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.