Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0631-03

Misys Laboratory System , Versions 5.2, 5.23 and 5.3

CliniSys, Inc / initiated 2003-02-07 / Terminated

Misys Healthcare Systems began a recall of Misys Laboratory System , Versions 5.2, 5.23 and 5.3 on . The reason FDA records is "Missing patient data on Location Chart Copy Cumulative Reports". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0631-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
CliniSys, Inc
Product
Misys Laboratory System , Versions 5.2, 5.23 and 5.3
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Missing patient data on Location Chart Copy Cumulative Reports.
FDA root cause
Other
Action
Recall notice was faxed to customers on 2/7/2003. A software correction will be developed and another notice will be made that this is available.
Quantity in commerce
478
Distribution
Nationwide and to Bermuda, Canada, United Kingdom, Ireland, Denmark, Saudi Arabia, United Arab Emirates.
Product codes and lots
Versions 5.2, 5.23 and 5.3