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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 06, 2003
Date Posted March 13, 2003
Recall Status1 Terminated 3 on May 07, 2004
Recall Number Z-0646-03
Recall Event ID 25641
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/
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
Manufacturer Reason
for Recall
Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
FDA Determined
Cause 2
Action Firm notified customers by fax on 2/6/2003. This included a workaround procedure. A correcting software package will be created and announced at a later date. Estimated completion date is May 1, 2003
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.