ARCHITECT CMV IGG REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ARCHITECT CMV IGG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA REVIEW, LABELING REVIEW, DEVICE HISTORY RECORDS REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 49574FN00 DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. IN-HOUSE SPECIFICITY TESTING WAS COMPLETED USING A RETAINED SAMPLE OF THE COMPLAINT LOT 49574FN00. ALL SPECIFICATIONS WERE MET, AND NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SPECIFICITY PERFORMANCE IS NOT IMPACTED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT CMV IGG REAGENT LOT 49574FN00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT CMV IGG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL RESULT = 54.9 AU/ML, REPEAT = 0.3 AU/ML, REPEAT WITH ADDITIONAL TUBES (SST, EDTA) = 0.3 AU/ML (B)(6) 2023 SID (B)(6) RESULTS ON ALL TUBES = 0.3 AU/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.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT CMV IGG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: 02AUG2023 SID 610005556 INITIAL RESULT = 54.9 AU/ML, REPEAT = 0.3 AU/ML, REPEAT WITH ADDITIONAL TUBES (SST, EDTA) = 0.3 AU/ML 03AUG2023 SID 437846035 RESULTS ON ALL TUBES = 0.3 AU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.