ELECSYS CMV IGM

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. ON (B)(6) 2025: ELECSYS CMV IGM RESULT WAS 0.58 COI (NON-REACTIVE). ELECSYS CMV IGG RESULT WAS 24.4 U/ML (REACTIVE). ON (B)(6) 2025: VIDAS CMV IGG RESULT WAS 25 AU/ML (REACTIVE). VIDAS CMV IGG AVIDITY RESULT WAS 40 AVI% (EQUIVOCAL). DIASORIN LIAISON CMV IGM RESULT WAS 32.7 AU/ML (REACTIVE). DIASORIN LIAISON CMV IGG RESULT WAS 69.8 AU/ML (REACTIVE) DIASORIN LIAISON CMV IGG AVIDITY RESULT WAS 0.199. ON (B)(6) 2025: ELECSYS CMV IGM RESULT WAS 0.54 COI (NON-REACTIVE). ELECSYS CMV IGG RESULT WAS 21.3 U/ML (REACTIVE).

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE REMAINING SAMPLE VOLUME WAS SENT TO ANOTHER LABORATORY FOR ADDITIONAL TESTING. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

QC AND CALIBRATION DATA WERE FOUND TO BE WITHIN THE EXPECTED RANGES. NO FURTHER RESULTS WERE PROVIDED FROM THE ADDITIONAL TESTING PERFORMED AT THE OTHER LABORATORY. SAMPLE MATERIAL WAS REQUESTED; HOWEVER, NO SAMPLE VOLUME WAS LEFT. THEREFORE, FURTHER INVESTIGATION COULD NOT BE PERFORMED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.