ARCHITECT LH
Received Dec 1, 2006 · Event occurred Sep 29, 2006
Report 1415939-2006-00032 · MDR key 789668
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-22
Lot number
33198M200
Product problems
- Replace
- Other (for use when an appropriate device code cannot be identified)
- Failure to Calibrate
- Device Displays Incorrect Message
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED THEY HAVE OBTAINED CALIBRATION FAILURES ON THE ARCHITECT LH ASSAY DUE TO ERROR CODE 1227 "ASSAY (LH) NUMBER (641) CALIBRATION FAILURE, FIT CONCENTRATION TOO HIGH FOR CAL F." THE ISSUE WAS RESOLVED BY SWITCHING TO A DIFFERENT REAGENT LOT. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS.
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.
Remedial action
- Recall