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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 19, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on June 02, 2004
Recall Number Z-0670-03
Recall Event ID 25679
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory System 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
520-570-2000
Manufacturer Reason
for Recall		 Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry
FDA Determined
Cause 2		 Other
Action Notification was made by FAX to customers. A procedureal work around was provided also. The firm will announce the availability of a software fix in the future.
Quantity in Commerce 464
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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