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 LIKELY CAUSE 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 ARCHITECT CMV IGG REAGENT LOT 49574FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS: RESULTS >/= 6.0 AU/ML ARE REACTIVE): MAY 2023 RESULT = NONREACTIVE. 17JUL2023 SID (B)(6) INITIAL RESULT = 15.4 AU/ML. 01AUG2023 SID (B)(6) INITIAL RESULT = 0.3 AU/ML, REPEAT = 0.2 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 FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS: RESULTS >/= 6.0 AU/ML ARE REACTIVE): (B)(6) 2023 RESULT = NONREACTIVE, (B)(6) 2023 SID (B)(6) INITIAL RESULT = 15.4 AU/ML, (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.3 AU/ML, REPEAT = 0.2 AU/ML , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.