ARCHITECT CEA

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT CEA RESULT WAS GENERATED FOR A PATIENT SAMPLE (ID (B)(6)). THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT: 316.60 NG/ML. RETEST 1: 0.5 NG/ML. RETEST 2: 315.32 NG/ML. RETEST 3: 316.72 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

HISTORICAL QUALITY METRICS WERE REVIEWED AND NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. COMPLAINT SEARCHES DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. NO PATIENT SAMPLE WAS AVAILABLE FOR INVESTIGATION. THEREFORE, TESTING OF SERUM BASED PANEL SAMPLES, WHICH MIMICS PATIENT SAMPLE, WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 96159FN00 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT LOT 96159FN00 IS PERFORMING ACCEPTABLY. FIELD DATA WAS REVIEWED WHICH DETERMINED THAT THE PATIENT MEDIAN RESULT FOR THE LIKELY CAUSE PRODUCT LOT IS COMPARABLE WITH OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. MANUFACTURING DOCUMENTATION WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.