OPTILITE® FREELITE® KAPPA FREE KIT (X10)

Description of Event or Problem

THIS EVENT DID NOT OCCUR IN THE USA. THIS EVENT OCCURRED IN FINLAND ON A DEVICE (OPTILITE® FREELITE® KAPPA FREE KIT (X10), MODEL #: LK016.1 0.OPT) THAT IS SIMILAR TO THE DEVICES (OPTILITE FREELITE KAPPA FREE KIT MODEL#: LK016.OPT.A (510(K) NUMBER: K231290), OPTILITE FREELITE KAPPA FREE KIT (X10) MODEL#: LK016.10.OPT.A (510(K) NUMBER: K231290) THAT ARE MARKETED IN THE USA. ON 9 JUNE 2026, THE BINDING SITE (TBS) WERE MADE AWARE BY A CUSTOMER IN FINLAND OF AN ALLEGED FALSELY ELEVATED KAPPA FREELITE FREE LIGHT CHAIN (FLC) RESULT OF 1269 MG/L OBTAINED ON THE OPTILITE ANALYSER, RELEASED FROM THE LABORATORY ON (B)(6) 2025 FOR A PATIENT BEING INVESTIGATED FOR POSSIBLE MYELOMA. THIS RESULT WAS REPORTED TO THE CLINICIAN. DUE TO THE FALSELY ELEVATED RESULT, THE PATIENT UNDERWENT A BONE MARROW BIOPSY ON (B)(6) 2026. FOLLOWING FURTHER TESTING, SIGNIFICANTLY LOWER KAPPA FLC RESULTS WERE OBTAINED, INDICATING THAT THE INITIAL RESULT WAS ERRONEOUS. THERE HAVE BEEN NO REPORTS OF DEATH OR INDICATION OF COMPLICATIONS FOLLOWING THE BONE MARROW BIOPSY. TBS CONSIDERS AN UNNECESSARY BONE MARROW BIOPSY TO BE AN INVASIVE PROCEDURE AND CLASS IT AS A SERIOUS MEDICAL EVENT.

Additional Manufacturer Narrative

TO DATE, NO ASSAY PERFORMANCE ISSUES HAVE BEEN IDENTIFIED.