OPTILITE® FREELITE® KAPPA FREE KIT

Description of Event or Problem

THE BINDING SITE WERE INFORMED BY THE CUSTOMER ON (B)(6) 2026 THAT 15 FALSELY LOW KAPPA FREE LIGHT CHAIN (FLC) PATIENT RESULTS HAD BEEN GENERATED USING THE FREELITE® KAPPA FREE LIGHT CHAIN ASSAY (LK016.OPT.A) ON THE OPTILITE® ANALYSER AND RELEASED BY THE LABORATORY ON (B)(6) 2026. THE ISSUE WAS IDENTIFIED DURING ROUTINE MID-DAY QUALITY CONTROL TESTING. THE AFFECTED SAMPLES WERE RETESTED ON (B)(6) 2026, AND THE CUSTOMER CORRECTED THE AFFECTED RESULTS THAT HAD BEEN RELEASED TO PHYSICIANS. THE ISSUE WAS DUE TO A LABORATORY SITE SPECIFIC ISSUE. ALTHOUGH NO SERIOUS INJURY OCCURRED, THE INCIDENT IS BEING REPORTED AS A PRECAUTION. REVIEW OF THE AFFECTED PATIENT SAMPLE RESULTS IDENTIFIED TWO LOW KAPPA FLC RESULTS THAT COULD POTENTIALLY LEAD TO SERIOUS INJURY IF A SIMILAR ISSUE WERE TO RECUR AND THE RESULTS WERE CONSIDERED IN ISOLATION. AS STATED IN THE IFU (INS016.OPT.A), FREE LIGHT CHAIN MEASUREMENT RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL FINDINGS.