ELECSYS FT4 IV

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV, ELECSYS FT3 III, AND ELECSYS ANTI-TSHR RESULTS FOR 1 PATIENT COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL FT4 RESULT WAS 1.72 NG/DL, AND THE REPEATED RESULT USING ANOTHER METHOD (CLIA ASSAY) IN ANOTHER LABORATORY WAS 1.03 NG/DL. THE INITIAL FT3 RESULT WAS 3.98 PG/ML, AND THE REPEATED RESULT USING ANOTHER METHOD (CLIA ASSAY) IN ANOTHER LABORATORY WAS 2.81 PG/ML. SAMPLE 2: ON 26-NOV-2025, THE ANTI-TSHR RESULT IS 2.9 IU/L. IT WAS ALLEGED THAT THE ANTI-TSHR RESULT WAS FALSELY ELEVATED, AND AN INTERFERENCE WITH THE ELECSYS ANTI-TSHR ASSAY WAS SUSPECTED. THIS MEDWATCH WILL APPLY TO THE ELECSYS FT4 IV ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FT3 III ASSAY. RESULTS FROM THE SAMPLE OBTAINED ON 26-NOV-2025: PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-TSHR ASSAY.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). INVESTIGATION FOR FT4 AND FT3 RESULTS REGARDING THE SAMPLE OBTAINED ON 21-DEC-2022: TO THE DIFFERENCES OF THE FT4 AND FT3 VALUES OF THE SAMPLE FROM 21-DEC-2022 GENERATED WITH THE ANALYZER FROM ROCHE DIAGNOSTICS AND WITH THE OUTSOURCED MEASUREMENT (TYPE OF ANALYZER NOT KNOWN), IT NEEDS TO BE TAKEN INTO ACCOUNT THAT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED AND DIFFERENCES IN REFERENCE MATERIALS/METHODS AND THE STANDARDIZATION METHODOLOGY USED. INVESTIGATION FOR THE ANTI-TSHR RESULT FOR THE SAMPLE OBTAINED ON 26-NOV-2025: ISSUES HAVE BEEN IDENTIFIED WITH THE ELECSYS ANTI-TSHR ASSAY, PARTICULARLY AROUND THE 1.75 IU/L MEDICAL DECISION POINT. ROCHE DIAGNOSTICS HAS ISSUED AN URGENT MEDICAL DEVICE CORRECTION FOR THIS ISSUE, ENTITLED "ELECSYS® ANTI-TSHR ASSAY ¿ DEVIATIONS ON COBAS® E 411, 402, AND 801 ANALYZERS." THIS CORRECTION HAS BEEN REPORTED TO FDA. ROCHE DIAGNOSTICS INVESTIGATED AND CONFIRMED THE CUSTOMERS' ALLEGATIONS. THE ROOT CAUSE FOR THE VARIATIONS IN THE ELECSYS ANTI-TSHR ASSAY WAS AN INSUFFICIENCY OF THE ASSAY'S ROUTINE PRODUCTION PROCESS. FOR THE PLATFORM-TO-PLATFORM DEVIATION (COBAS E 411 VS. COBAS E 402/E 801), DIFFERENCES AROSE DUE TO AN INSUFFICIENT ALIGNMENT CONCEPT BETWEEN THE PLATFORMS. THESE VARIATIONS WERE FURTHER INFLUENCED BY UPDATES TO THE ROUTINE PRODUCTION PROCESS FOR THIS ASSAY. FOR THE LOT-TO-LOT DEVIATION ON E 411, MEASURES TAKEN TO ENHANCE ROBUSTNESS LED TO ADDITIONAL SHIFTS. CUSTOMERS WERE ADVISED TO IMMEDIATELY DISCONTINUE USING AND DISCARD THE AFFECTED LOT NUMBERS: 840183 AND 874011 ON THE COBAS E402/E801 ANALYZER. 840177 ON THE COBAS E411 ANALYZER. CUSTOMERS WERE ADVISED TO SWITCH TO THE NEW UNAFFECTED LOT NUMBERS: 908953 ON THE COBAS E402/E801 ANALYZER. 906872 ON THE COBAS E411 ANALYZER. THE COBAS E601 AND E602 MODULES ARE NOT AFFECTED AND CAN BE USED WITH ALL CURRENTLY AVAILABLE LOTS AND WITH THE UPCOMING LOTS WITHOUT RESTRICTIONS.