Class 2 Device Recall MISYS

• Date Initiated by Firm: September 29, 2005
• Date Posted: October 22, 2005
• Recall Status: Terminated on February 10, 2006
• Recall Number: Z-0088-06
• Recall Event ID: 33732
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory version 6.1 - Microbiology Module
• Code Information: version 6.1
• FEI Number: 1000306472
• Recalling Firm/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711-3609
• For Additional Information Contact: Thomas E. Goelz; 520-570-2408
• Manufacturer Reason for Recall: Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000.
• FDA Determined Cause: Other
• Action: Telephone calls and emails dated 9/29/05 to all consignees in production. Product Safety Noticed dated 9/29/2005 was faxed to all consignees testing the product.
• Quantity in Commerce: 67
• Distribution: Nationwide and Canada, Denmark, Emirates, Saudi Arabia, United Kingdom
• 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.