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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 FirmMarch 19, 2003
Date PostedJuly 02, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall NumberZ-0972-03
Recall Event ID 26501
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMysys Laboratory System Version 5.3
Code Information Version 5.3.
FEI Number 1000306472
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information ContactBarbara Brown
520-733-6403
Manufacturer Reason
for Recall		Abnormal results are flagged as normal.
FDA Determined
Cause 2		Other
ActionThis is a completed recall. Consignee has had the software patch installed and reports it to be functional as of March 19, 2003. Recall notice was also sent that same day.
Quantity in Commerce1
DistributionOnly to one hospital in Nebraska.
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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