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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 July 21, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 15, 2004
Recall Number Z-0238-04
Recall Event ID 27499
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.
Code Information Version 5.3 build 63 thru 6.3.2 and LabAccess Results.
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711-3609
For Additional Information Contact Dave Cox
520-733-6403
Manufacturer Reason
for Recall		 Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.
FDA Determined
Cause 2		 Other
Action A temporary procedural workaround was communicated by fax to customers in Product Safety Notice PSN-03-L33 on July 21, 2003. Asecond Notice (L33A) was sent to customers to futher facilitate the recall.
Quantity in Commerce 125
Distribution Nationwide, Canada, Saudi Arabia, United Kingdom.
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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