Class 2 Device Recall

• Date Initiated by Firm: July 22, 2003
• Date Posted: September 11, 2003
• Recall Status: Terminated on June 25, 2004
• Recall Number: Z-1217-03
• Recall Event ID: 27029
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
• Code Information: Version 5.2 through 5.3.2 using LabAccess Results
• 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 design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
• FDA Determined Cause: Other
• Action: Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 2003.
• Quantity in Commerce: 171
• Distribution: Nationwide and to United Kingdom, Canada, Denmark, Ireland, 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.