ARCHITECT LH
Received Dec 12, 2006 · Event occurred Aug 9, 2006
Report 1415939-2006-00067 · MDR key 796800
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-22
Lot number
33198M200
Product problems
- Incorrect Or Inadequate Test Results
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED A TREND SHIFT UPWARD IN NON-ABBOTT CONTROLS (BIORAD IA PLUS LOT 40170) UPON THE RECEIPT OF ARCHITECT LH REAGENT LOT 33198M200. NO PATIENT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. 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. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Recall