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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 28, 2003
Date Posted April 02, 2003
Recall Status1 Terminated 3 on June 02, 2004
Recall Number Z-0686-03
Recall Event ID 25797
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory version 5.3
Code Information Version 5.3 only.
Recalling Firm/
Manufacturer
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
Manufacturer Reason
for Recall
Patient results do not update properly when modified using on-line entry function.
FDA Determined
Cause 2
Other
Action Product Safety Notice (PSN-03-L10) was sent to all affected clients by fax on 2/28/2003. It contained a procedural workaround. An announcement of the availability of a software upgrade or fix will be made when it is available.
Quantity in Commerce 460
Distribution Nationwide and to United Kingdom, Ireland, Denmark, Canada, 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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