ARCHITECT LH

Description of Event or Problem

THE CUSTOMER STATES THAT ARCHITECT LH ASSAY FAILS TO CALIBRATE USING ARCHITECT LH REAGENT LOT NUMBER 33198M100. THE CUSTOMER ALSO STATES THAT QC RESULTS WERE LOWER THAN EXPECTED. NO SUSPECT PATIENT RESULTS WERE GENERATED OR REPORTED OUT OF THE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THIS ISSUE WAS IDENTIFIED WHILE INVESTIGATING AN INCREASE IN CUSTOMER COMPLAINTS FOR UPWARD SHIFTS IN NON-ABBOTT CONTROL AND PATIENT SAMPLE RESULTS, AS WELL AS CALIBRATION ERRORS. SPECIFICALLY, ERROR CODE 1227 "ASSAY (LH) NUMBER (641) CALIBRATION FAILURE, FIT CONCENTRATION TOO HIGH FOR CAL F" MAY BE GENERATED, WHICH WOULD RESULT IN FAILURE TO OBTAIN A VALID CALIBRATION CURVE. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THE AFFECTED LOTS OF ARCHITECT LH REAGENTS. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.