Class 2 Device Recall

• Date Initiated by Firm: February 06, 2003
• Date Posted: March 13, 2003
• Recall Status: Terminated on May 07, 2004
• Recall Number: Z-0646-03
• Recall Event ID: 25641
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory System Version 5.3
• Code Information: Version 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: Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
• FDA Determined Cause: Other
• Action: Firm notified customers by fax on 2/6/2003. This included a workaround procedure. A correcting software package will be created and announced at a later date. Estimated completion date is May 1, 2003
• 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.