ARCHITECT LH
Received Dec 7, 2006 · Event occurred Sep 8, 2006
Report 1415939-2006-00047 · MDR key 795654
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-27
Lot number
33198M200
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS ISSUE WAS IDENTIFIED WHILE INVESTIGATING AN INCREASE IN CUSTOMER COMPLAINTS FOR UPWARD SHIFTS IN NON-ABBOTT CONTROLS AND PATIENT SAMPLES, 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.
Description of Event or Problem
THE CUSTOMER STATES THAT WHEN THEY BEGAN USING ARCHITECT I2000 LH REAGENT LOT 33198M200, NON-ABBOTT CONTROLS SHIFTED MORE THAN TWO STANDARD DEVIATIONS COMPARED TO THE PREVIOUS LOT OF REAGENT. THERE IS NO IMPACT TO PATIENT MANAGEMENT.
Remedial action
- Recall