OtherJJE
AIA-600II
Received Feb 24, 2009 · Event occurred Jan 25, 2008
Report 3005529799-2009-00001 · MDR key 1341373
Device
Generic name
Automated Immunoassay System
Manufacturer
Tosoh Corp.Model number
AIA-600IICatalog number
019328
Lot number
*
Product problems
- Failure to Calibrate
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED TO TOSOH BIOSCIENCE, INC. THAT THE CALIBRATION WAS NOT CORRELATING. THE ACCOUNT STATED THAT THEY HAD TWO AIA-600II ANALYZERS AND ONE IS NOT WORKING PROPERLY.