ELECSYS FOLATE III

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 90 PATIENTS' SAMPLES TESTED WITH THE ELECSYS FOLATE G3 ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1: INITIAL RESULT: 2.36 NG/ML. REPEAT RESULT: 4.38 NG/ML. SAMPLE 2: INITIAL RESULT: 3.75 NG/ML. REPEAT RESULT: 6.65 NG/ML. SAMPLE 3 WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 3.71 NG/ML. REPEAT RESULT: 4.92 NG/ML. THE REPORTER STATED THAT THE PATIENT SAMPLE RESULTS SHOWED A NEGATIVE BIAS AND WERE NOT RESOLVED BY RECALIBRATION, PROMPTING THE RERUN. THE REPEAT RESULTS WERE FROM A SIEMENS ANALYZER AND WERE DEEMED CORRECT.

Additional Manufacturer Narrative

THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE CALIBRATION WAS PERFORMED ON 16-JUN-2025 AND WAS CONSISTENT WITH PAST DATA AND SIMILAR TO THE ROCHE SIGNAL RANGES. THE INVESTIGATION NOTED A QC DRIFT. 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. THE INVESTIGAITON NOTED THAT THE SIEMENS ATTELICA RECOVERY IS HIGHER THAN ROCHE AND OTHER METHODS. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A NEGATIVE BIAS OF THE BIOTIN-UPDATE ELECSYS FOLATE III ASSAY. THE CURRENTLY AVAILABLE REAGENT LOTS OF THE REPORTED ELECSYS FOLATE III ASSAY VERSION MAY BE USED UNTIL THEIR EXPIRY DATES.