Class 3 Device Recall

• Date Initiated by Firm: June 23, 2003
• Date Posted: August 07, 2003
• Recall Status: Terminated on April 23, 2004
• Recall Number: Z-1093-03
• Recall Event ID: 26717
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.
• Code Information: Versions 5.3 up to 5.3.2.
• FEI Number: 1000306472
• Recalling Firm/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711
• For Additional Information Contact: Barbara Brown; 520-733-6403
• Manufacturer Reason for Recall: Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
• FDA Determined Cause: Other
• Action: Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER.
• Quantity in Commerce: 157
• Distribution: Nationwide and to United Kingdom, Ireland, Canada, 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.