ARCHITECT LH
Received Dec 4, 2006 · Event occurred Nov 22, 2006
Report 1415939-2006-00041 · MDR key 794377
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-27
Lot number
33198M100
Product problems
- Unknown (for use when the device problem is not known)
- Failure to Calibrate
- Device Displays Incorrect Message
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS MEDWATCH IS BEING FILED DUE TO AN ISSUE IDENTIFIED WHILE INVESTIGATING AN INCREASE IN CUSTOMER COMPLAINTS FOR UPWARD SHIFTS IN NON-ABBOTT CONTROL AND PT 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 WITH THESE LOTS, WHICH WOULD RESULT IN FAILURE TO OBTAIN A VALID CALIBRATION CURVE. A RECALL WAS ISSUED FOR ARCHITECT LH REAGENT LIST NUMBERS 6C25-22 LOT NUMBERS 33198M200 AND 41861M100, LIST NUMBER 6C25-27 LOT NUMBER 33198M201 AND LIST NUMBER 6C25-30 LOT NUMBER 33871M100. THE ISSUE WAS REPORTED UNDER 21 CFR 806 TO THE SAN FRANCISCO FDA DISTRICT OFFICE ON 11/30/2006. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THE AFFECTED LOTS OF ARCHITECT LH REAGENTS.
Additional Manufacturer Narrative
THIS IS THE FINAL REPORT. AN INVESTIGATION IS IN PROCESS.