OPTILITE® FREELITE® LAMBDA FREE KIT

Description of Event or Problem

THIS EVENT OCCURRED IN THE UNITED KINGDOM AND DID NOT INVOLVE A DEVICE MARKETED IN THE USA. THE AFFECTED DEVICE (OPTILITE® FREELITE® LAMBDA FREE KIT, MODEL LK018.OPT) IS SIMILAR TO THE U.S.-MARKETED DEVICES OPTILITE® FREELITE® LAMBDA FREE KIT, MODEL LK018.OPT.A AND LK018.10.OPT.A (510(K) K231290). THE AFFECTED DEVICE WAS RUN ON THE OPTILITE ANALYSER (MODEL IE700, 510(K) EXEMPT). ON 4 JUNE 2026, THE BINDING SITE WAS INFORMED THAT TWO FALSELY LOW LAMBDA FREE LIGHT CHAIN (FLC) RESULTS (<1.32 MG/L) HAD BEEN RELEASED BY THE LABORATORY. THE RESULTS WERE CORRECTED TO 2144.5 MG/L AND 622.54 MG/L ON 4 JUNE 2026. BOTH DISCREPANT RESULTS WERE IDENTIFIED AND CORRECTED BEFORE ANY TREATMENT DECISIONS WERE MADE. ALTHOUGH NO PATIENT HARM OCCURRED, THE ISSUE IS BEING REPORTED AS A MATTER OF CAUTION. SHOULD THE ISSUE REOCCUR, AN UNDETECTED FALSELY LOW FLC RESULTS COULD POTENTIALLY LEAD TO DELAYED OR INAPPROPRIATE CLINICAL MANAGEMENT. FLC RESULTS SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL FINDINGS, AS STATED IN THE INSTRUCTIONS FOR USE (INS018.OPT REV. 4). THE INITIAL INVESTIGATION INDICATES THE EVENT WAS MOST LIKELY ASSOCIATED WITH A SITE-SPECIFIC INSTRUMENT ISSUE. THE INVESTIGATION IS ONGOING, AND NO ASSAY PERFORMANCE ISSUES HAVE BEEN IDENTIFIED TO DATE.

Additional Manufacturer Narrative

N.A.