N LATEX FLC KAPPA

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY DEPRESSED FLC KAPPA (FREE KAPPA LIGHT CHAINS) AND FLC LAMBDA (FREE LAMBDA LIGHT CHAINS) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC LAMBDA AND N LATEX FLC KAPPA ON BN II INSTRUMENT, COMPARED TO ALTERNATE METHOD. AFFECTED PATIENT SAMPLE WAS TESTED ON TWO DATES (B)(6) 2026) AND WITH TWO REAGENTS (N LATEX FLC KAPPA AND N LATEX FLC LAMBDA). THIS MDR IS ABOUT THE FLC KAPPA RESULT OBTAINED ON 03-JUN-2026, RESULTS OBTAINED ON 01-JUN-2026 AND WITH N LATEX FLC LAMBDA ARE REFERENCED IN SEPARATE MDRS. SIEMENS IS INVESTIGATING. NOTE: THE N LATEX FLC KAPPA REAGENT IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER 10873629. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED FLC KAPPA (FREE KAPPA LIGHT CHAINS) AND FLC LAMBDA (FREE LAMBDA LIGHT CHAINS) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC LAMBDA AND N LATEX FLC KAPPA ON BN II INSTRUMENT, COMPARED TO ALTERNATE METHOD. BOTH, BN II AND ALTERNATE METHOD RESULTS WERE REPORTED TO THE PHYSICIAN. RESULTS OBTAINED WITH ALTERNATE METHOD ARE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED FLC KAPPA AND FLC LAMBDA RESULTS.