ATELLICA CH

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ATELLICA CH TACROLIMUS (TACR) RESULTS WHICH WERE ERRONEOUS WHEN USING LOT# 150152 RELATIVE TO REPEAT TESTING ON ALTERNATE METHODS. INITIAL DEPRESSED TACR RESULTS WERE OBTAINED FOR MULTIPLE PATIENT SAMPLES IN QUESTION. THE DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE METHOD (ABBOTT ARCHITECT 1000), AND ALSO AT AN ALTERNATE FACILITY (METHOD UNKNOWN). HIGHER RESULTS WERE PRODUCED WHICH WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER REPORTED OBSERVATION OF DEPRESSED ATELLICA CH TACROLIMUS (TACR) RESULTS WHICH WERE ERRONEOUS RELATIVE TO REPEAT TESTING ON ALTERNATE METHODS. SIEMENS IS EVALUATING THE EVENT.

Additional Manufacturer Narrative

AN INITIAL MDR 2432235-2026-00062 WAS FILED ON 27-FEB-2026. CORRECTED DATA: IN THE INITIAL REPORT, THE EVENT DATE WAS MENTIONED AS 20-JAN-2026, WHICH WAS BEYOND THE LOT¿S EXPIRY. HOWEVER, UPON CLARIFICATION WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE LOT WAS NOT USED PAST ITS EXPIRY DATE OF 27-DEC-2025. THE CUSTOMER FACILITY USED THE LOT FOR TESTING PATIENT SAMPLES ON OR BEFORE (B)(6) 2025, AND THE EXACT DATE OF THE EVENT REMAINS UNKNOWN.