AXSYM RUBELLA LGG ANTIBODY

Description of Event or Problem

THE CUSTOMER CONTACTED ABBOTT TO REPORT FAILED CALIBRATOINS OF THE AXSYM RUBELLA LGG ASSAY WHERE ERROR CODE 1111 (CALIBRATION CHECK FAILURE, M CAL 1, RESPONSE TOO LARGE) WERE GENERATED WITH NEW CALIBRATORS AND REAGENTS. THE CUSTOMER USED DISTILLED WATER INSTEAD OF CALIBRATOR 1 AND THE CALIBRATION WAS SUCCESSFUL WITH CONTROLS WITHIN RANGE. THE CUSTOMER WANTED TO USE THE SUCCESSFUL CALIBRATION AND WAS ADVISED NOT TO USE FOR REPORTING PATIENT RESULTS, THEREFORE, THE CUSTOMER WAS SENT A NEW LOT OF CALIBRATORS. THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE CALIBRATORS BEFORE RECALIBRATION AND A SUCCESSFUL CALIBRATION WAS ACHIEVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.

Additional Manufacturer Narrative

(NO CONSEQUENCE OR IMPACT TO PATIENT), (CALIBRATION ERROR), (ERROR MESSAGE GIVEN), THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.