ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS ON MULTIPLE PATIENTS FROM MULTIPLE ALINITY I PROCESSING MODULE. THE RESULTS PROVIDED WERE: SID (B)(6): 27YRS OLD FEMALE: ON ALINITY (B)(6): INITIAL= > 64.35 PMOL/L /REPEATED=16.64 AND 13.57 PMOL/L. SID (B)(6): 25YRS OLD MALE: ON ALINITY (B)(6): INITIAL=> 64.35 PMOL/L /REPEATED=16.24 AND 19.42 PMOL/L. ON (B)(6) 2026 SID (B)(6): 64YRS OLD FEMALE: INITIAL=23.31 PMOL/L /REPEATED=14.99 PMOL/L. SID (B)(6): 26YRS OLD MALE: INITIAL=25.22 PMOL/L /REPEATED=14.5 PMOL/L. SID (B)(6): 21YRS OLD FEMALE: INITIAL=20.24 PMOL/L /REPEATED=15.0 PMOL/L. SID (B)(6): 34YRS OLD MALE: INITIAL=26.23 PMOL/L /REPEATED=14.63 PMOL/L. LABORATORY REFERENCE RANGE FOR FT4=9.01 TO 19.05 PMOL/L. NO INDIVIDUAL FT4 RESULTS PROVIDED OR SPECIFY THE REAGENT LOTS IN USE FOR THE PATIENT SAMPLES THE SAME INFORMATION WAS REPORTED ACROSS BOTH REAGENT LOTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.