ARCHITECT CYCLOSPORINE REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS FOR ONE 6 YEAR OLD MALE PATIENT DIAGNOSED WITH IDIOPATHIC APLASTIC ANEMIA. THE PATIENT IS ON THE FOLLOWING MEDICATION, SANDIMMUN 60 MG TWICE DAILY, NOXAFIL (POSACONAZOLE), PREDNISONE. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6), PROCESSED ON (B)(6) 2026 = 1335.6 AND 1420.8 NG/ML REPEATED AGAIN ON (B)(6) 2026 = 1148.2 AND 1107.7 NG/ML SID: (B)(6) PROCESSED ON 20JUN2026 RESULT = 116 NG/ML. HISTORY SINCE (B)(6) 2026, MAXIMUM VALUE 200 NG/ML UREA, CREATININE, LIVER ENZYMES WITHIN NORMAL RANGE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED; NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3R30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L75 WITH 510K/PMA/BLA NUMBER K080751.