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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 FirmApril 14, 2003
Date PostedMay 29, 2003
Recall Status1 Terminated 3 on April 21, 2004
Recall NumberZ-0867-03
Recall Event ID 26135
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys Laboratory System versions 5.2, 5.23, 5.3, 5.3.1 and 5.3.2.
Code Information versions 5.2, 5.23, 5.3, 5.3.1 and 5.3.2.
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information ContactBarbara Browne
520-733-6403
Manufacturer Reason
for Recall		Incorrect results could be filed.
FDA Determined
Cause 2		Other
ActionThe firm sent Product Safety Notice PSN-03-L18 by fax to customers on 4/14/2003.
Quantity in Commerce193
DistributionNationwide and to Ireland, Canada, Denmark, United Kingdom, 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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