ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I FREE T4 FOR ONE FEMALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE IS 11-17.1 PMOL/L): SID (B)(6), INITIAL FREE T4 RESULT= <5.41 PMOL/L; REPEAT RESULT= 15.21 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I FREE T4 ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 73465UD01. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. IN HOUSE TESTING WAS PERFORMED USING A RETAINED KIT OF LOT 73465UD00, WHICH CONTAINS THE SAME BULK MATERIAL AS LOT 73465UD01. TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 REAGENT FOR LOT 73465UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I FREE T4 FOR ONE FEMALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE IS 11-17.1 PMOL/L): SID (B)(6), INITIAL FREE T4 RESULT= <5.41 PMOL/L; REPEAT RESULT= 15.21 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.