Class 2 Device Recall

• Date Initiated by Firm: February 07, 2003
• Date Posted: March 12, 2003
• Recall Status: Terminated on June 02, 2004
• Recall Number: Z-0631-03
• Recall Event ID: 25624
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory System , Versions 5.2, 5.23 and 5.3
• Code Information: Versions 5.2, 5.23 and 5.3
• FEI Number: 1000306472
• Recalling Firm/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711
• For Additional Information Contact: Mark Ellis; 520-570-2000
• Manufacturer Reason for Recall: Missing patient data on Location Chart Copy Cumulative Reports.
• FDA Determined 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.
• 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.