ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS THAT NEGATIVE ON VIRCELL ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 INITIAL=106.6 AU/ML (> OR = 6.0 AU/ML=REACTIVE) /ON VIRCLIA (VIRCELL)=NON-DETECTED (NO ACTUAL RESULTS PROVIDED) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE COMPLAINT EVALUATION 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 SPECIFICITY TESTING FOR ALINITY I CMV IGG REAGENT LOT 54010FN00. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. IN-HOUSE TESTING WAS PERFORMED WITH A RETAINED KIT OF LOT 54010FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. PER THE PRODUCT PACKAGE INSERT, IF THE ALINITY I CMV IGG RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., RESULTS OF OTHER TESTS (CMV IGM, CMV IGG AVIDITY), CLINICAL IMPRESSIONS, ETC. A MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CMV IGG, REAGENT LOT 54010FN00.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS THAT NEGATIVE ON VIRCELL ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON 17JAN2024 INITIAL=106.6 AU/ML (> OR = 6.0 AU/ML=REACTIVE) /ON VIRCLIA (VIRCELL)=NON-DETECTED (NO ACTUAL RESULTS PROVIDED) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.