ARCHITECT B12 REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT B12 RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF CUSTOMER DATA ALIGNED WITH CUSTOMER¿S ISSUE AND NO ADDITIONAL ISSUES WERE IDENTIFIED. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT B12 ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 71042UD00. THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 71042UD00. TESTING MEETS ACCEPTANCE CRITERIA INDICATING THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT B12 ASSAY FOR LOT NUMBER 71042UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT B12 RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE A WHITE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED DIAGNOSTIC RANGE: 83-2000 PG/ML). (B)(6) 2025, SID (B)(6) INITIAL RESULT = 1855 PG/ML, 2ND RESULT = 408 PG/ML, 3RD RESULT = 255 PG/ML. 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K61-25 (ARCHITECT B12) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K61-27 / 37 (ARCH B12) WITH 510K/PMA/BLA NUMBER K121314. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT B12 RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE A WHITE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED DIAGNOSTIC RANGE: 83-2000 PG/ML). ON (B)(6) 2025, SID (B)(6), INITIAL RESULT = 1855 PG/ML, 2ND RESULT = 408 PG/ML, 3RD RESULT = 255 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.