Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0325-03

Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus

CliniSys, Inc / initiated 2002-10-24 / Terminated / root cause: software

Sunquest Information Systems began a recall of Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus on . The reason FDA records is "Interfacing software systems have inconsistent character recognition characteristics". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0325-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
CliniSys, Inc
Product
Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Interfacing software systems have inconsistent character recognition characteristics.
Root cause tag
software
FDA root cause
Other
Action
A recall notice was sent to hospitals on October 24, 2002. It communicated a temporary procedure to work around the problem. Also mentioned was the availabllity of a utility to detect and report suspected duplicate Medical Record Numbers.
Quantity in commerce
190
Distribution
Nationwide and to Denmark, Bermuda, United Kingdom, Saudi Arabia, Canada.
Product codes and lots
Versions 5.2, 5.23 and 5.3 with ADT Interface to CoPathPlus.