Class 3 Device Recall

• Date Initiated by Firm: December 20, 2002
• Date Posted: January 30, 2003
• Recall Status: Terminated on December 01, 2004
• Recall Number: Z-0495-03
• Recall Event ID: 25378
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory, GUI version 5.3
• Code Information: Version 5.3
• Recalling Firm/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711
• For Additional Information Contact: Mark Ellis; 520-570-3609
• Manufacturer Reason for Recall: An incorrect collection date and time may be accepted and filed to the patient file.
• FDA Determined Cause: Other
• Action: The firm's recall notice was sent by fax to all customers on Jan. 3, 2003. It communicated a procedural workaround and the availability of product corrections.
• Quantity in Commerce: 465
• Distribution: Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates.
• 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.