ELECSYS FOLATE III

Additional Manufacturer Narrative

THE METHOD USED AT THE OTHER LABORATORY WAS THE SIEMENS ATELLICA (CHEMILUMINESCENCE IMMUNOASSAY). BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. AS THE SAMPLES ARE NO LONGER AVAILABLE, NO FURTHER INVESTIGATION IS POSSIBLE.

Additional Manufacturer Narrative

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

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FOLATE III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE ONCOLOGISTS CONTACTED THE LABORATORY BECAUSE THEY SAW A HIGHER NUMBER OF PATIENTS WITH FOLIC ACID DEFICIENCY. THE FOLLOWING EXAMPLES WERE PROVIDED: EXAMPLE 1 INITIAL RESULT WAS APPROXIMATELY 7 NMOL/L (RATED AS FOLATE DEFICIENT), AND THE REPEAT RESULT AT ANOTHER LABORATORY WAS APPROXIMATELY 17 NMOL/L (NO FOLATE DEFICIENCY). EXAMPLE 2 INITIAL RESULT WAS 10.1 NMOL/L, AND THE REPEAT RESULT AT ANOTHER LABORATORY WAS 16.4 NMOL/L. ON 22-DEC-2025, EXAMPLE 3 INITIAL RESULT WAS 7.3 NMOL/L, AND THE REPEAT RESULT AT ANOTHER LABORATORY WAS 14.7 NMOL/L.