ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I FREE T4 RESULTS. SID (B)(6) GENERATED >5 NG/DL, REPEATED 1.26 NG/DL, REPEATED 1.98 NG/DL, REPEATED 0.99 NG/DL. NORMAL RANGE 0.7-1.48 NG/DL. THE CUSTOMER DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY, AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 71236UD00. HOWEVER, TESTING PERFORMED USING RETAINED KITS FROM LOT 71236UD00 SHOWED THAT ALL RESULTS PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT OR ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 71236UD00 WAS IDENTIFIED.

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: THE CUSTOMER DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I FREE T4 RESULTS. SID (B)(6) GENERATED 5 NG/DL, REPEATED 1.26 NG/DL, REPEATED 1.98 NG/DL, REPEATED 0.99 NG/DL. NORMAL RANGE 0.7-1.48 NG/DL. THE CUSTOMER DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.