ELECSYS TG II

Additional Manufacturer Narrative

CALIBRATION DATA WAS ACCEPTABLE. ALL THREE CONTROL LEVELS WERE WITHIN RANGE ON 06-NOV-2025. ONLY THE THIRD LEVEL OF CONTROL WAS MEASURED ON 03-DEC-2025 AND IT WAS ACCEPTABLE. FOR THE REMAINING PROVIDED CONTROL DATA, NO ABNORMALITIES OR OUTLIERS WERE OBSERVED. BASED ON CALIBRATION AND CONTROL DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH A PRE-ANALYTIC SAMPLE HANDLING ISSUE OR CONTAMINATION.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TG II RESULTS FOR 1 PATIENT ON A COBAS 6000 E601 MODULE. THE CUSTOMER HAS A MEDICAL HISTORY OF TOTAL THYROIDECTOMY AND HAS HAD CONSISTENT PREVIOUS TG RESULTS OF <0.04 NG/ML SINCE 2021. ON (B)(6) 2025, THE INITIAL RESULT WAS 26.27 NG/ML. THE REPEAT RESULT WAS 27.99 NG/ML. THE PATIENT QUESTIONED THE RESULTS AND THEY WENT TO ANOTHER LABORATORY TO HAVE A NEW SAMPLE COLLECTED. THE TG RESULT FROM THE OTHER LABORATORY WAS <0.04 NG/ML. THE EXACT DATE OF TESTING WAS NOT PROVIDED. ON (B)(6) 2025, THE PATIENT HAD A NEW SAMPLE COLLECTED AND TESTED AT THE CUSTOMER SITE. AND THE TG RESULT WAS <0.04 NG/ML WITH FLAG. ON (B)(6) 2025, THE CUSTOMER REPEATED THE SAMPLE FROM (B)(6) 2025 AND THE RESULT WAS 27.76 NG/ML. THE SAMPLE FROM (B)(6) 2025 WAS ALSO REPEATED AND THE RESULT WAS <0.04 NG/ML WITH FLAG.