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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmDecember 20, 2002
Date PostedJanuary 30, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall NumberZ-0495-03
Recall Event ID 25378
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys Laboratory, GUI 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 ContactMark Ellis
520-570-3609
Manufacturer Reason
for Recall		An incorrect collection date and time may be accepted and filed to the patient file.
FDA Determined
Cause 2		Other
ActionThe firm's recall notice was sent by fax to all customers on Jan. 3, 2003. It communicated a procedural workaround and the availability of product corrections.
Quantity in Commerce465
DistributionNationwide and to United Kingdom, Ireland, Canada, Denmark, 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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