ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I CMV IGG LOT# 58475FN00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 58475FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024, SID (B)(6) = 31.5 AU/ML, REPEATED ON (B)(6) 2024 = 0.265 / 0.299 / 0.120 / 0.121 AU/ML (= 6.0 IS REACTIVE). 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 A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = 31.5 AU/ML, REPEATED ON (B)(6) 2024 = 0.265 / 0.299 / 0.120 / 0.121 AU/ML (= 6.0 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.