AXSYM RUBELLA LGG ANTIBODY
Received Mar 12, 2009 · Event occurred Feb 12, 2008
Report 1415939-2008-00301 · MDR key 1341443
Device
Generic name
Meia For The Measurement Of Lgg Antibody To The Rubella Virus
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
3B23-20
Lot number
56659M200
Product problems
- Calibration Error
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED ABBOTT STATING THE AXSYM RUBELLA LGG ASSAY CALIBRATION FAILED USING NEW REAGENTS AND CALIBRATORS. THE CUSTOMER CENTRIFUGED THE CALIBRATORS AND A SUCCESSFUL CALIBRATION WAS ACHIEVED. ABBOTT REQUESTED THE FAILED CALIBRATION DATA FOR EVALUATION. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Other