ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

CORRECTION TO ADDITIONAL MFR NARRATIVE: TO REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I FREE T4 ASSAY DID IDENTIFY INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT LOT 76559UD01, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 07P70. FROM REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I FREE T4 ASSAY DID NOT IDENTIFY INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT LOT 76559UD01, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 07P70.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS ON A 28YRS OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL= 19.15 PMOL/L /REPEATED= 14.53 PMOL/L, LABORATORY REFERENCE RANGE FOR FT4=9.01 TO 19.05 PMOL/L, ADDITIONAL INFORMATION PROVIDED: TSH=1.6565 UIU/ML (REFERENCE RANGE=0.35 TO 4.94 UIU/ML); FT3=5.17 PMOL/L (REFERENCE RANGE=2.43 TO 6.01 PMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

UPDATED SECTION D4 EXPIRATION DATE: TO 05/12/2026 FROM 12/5/2026: PRIMARY UDI NUMBER: TO (B)(4) FROM (B)(4). THE COMPLAINT INVESTIGATION 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 ACCURACY TESTING OF ALINITY I FREE T4 REAGENT LOT: 76559UD01. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I FREE T4 ASSAY DID NOT IDENTIFY INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT LOT 76559UD01, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 07P70. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND ISSUE. ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT 76559UD00. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEM ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT: 76559UD01 WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6); 28YRS OLD FEMALE. 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 A 28YRS OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6), INITIAL= 19.15 PMOL/L /REPEATED= 14.53 PMOL/L, LABORATORY REFERENCE RANGE FOR FT4=9.01 TO 19.05 PMOL/L, ADDITIONAL INFORMATION PROVIDED: TSH=1.6565 UIU/ML (REFERENCE RANGE=0.35 TO 4.94 UIU/ML); FT3=5.17 PMOL/L (REFERENCE RANGE=2.43 TO 6.01 PMOL/L) , THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.