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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 28, 2003
Date PostedApril 02, 2003
Recall Status1 Terminated 3 on June 02, 2004
Recall NumberZ-0686-03
Recall Event ID 25797
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys Laboratory version 5.3
Code Information Version 5.3 only.
FEI Number 1000306472
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
ActionProduct 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 Commerce460
DistributionNationwide and to United Kingdom, Ireland, Denmark, Canada, Bermuda, Saudi Arabia, United Arab Emirates.
Total Product Life CycleTPLC 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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