ARCHITECT LH
Received Dec 7, 2006 · Event occurred Aug 31, 2006
Report 1415939-2006-00057 · MDR key 795652
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-22
Lot number
33198M200
Product problems
- Other (for use when an appropriate device code cannot be identified)
- Incorrect Or Inadequate Test Results
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED QC AND PATIENT RESULTS HAVE SHIFTED UP APPROXIMATELY 10% ON THE ARCHITECT LH ASSAY. 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. AN INVESTIGATION IS IN THE PROCESS.
Remedial action
- Recall