Class 2 Device Recall Misys Laboratory

Date Initiated by Firm	December 06, 2002
Date Posted	January 30, 2003
Recall Status¹	Terminated ³ on February 26, 2013
Recall Number	Z-0497-03
Recall Event ID	25238
Product Classification	Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product	Reference Library Interface Version 5.3
Code Information	Version 5.3
FEI Number	1000306472
Recalling Firm/ Manufacturer	Sunquest Information Systems 4801 E Broadway Blvd Tucson AZ 85711
For Additional Information Contact	Mark Ellis 520-570-2000
Manufacturer Reason for Recall	Software system defect resulting in incomplete patient results information.
FDA Determined Cause ²	Other
Action	Product Safety Notice, PSN-02-L31 will be faxed to all affected customers. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.
Quantity in Commerce	30
Distribution	Nationwide
Total Product Life Cycle	TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. ² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. ³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.