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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm December 20, 2002
Date Posted January 30, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall Number Z-0495-03
Recall Event ID 25378
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory, GUI version 5.3
Code Information Version 5.3
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
520-570-3609
Manufacturer Reason
for Recall		 An incorrect collection date and time may be accepted and filed to the patient file.
FDA Determined
Cause 2		 Other
Action The firm's recall notice was sent by fax to all customers on Jan. 3, 2003. It communicated a procedural workaround and the availability of product corrections.
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.
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