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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 January 17, 2003
Date Posted March 26, 2003
Recall Status1 Terminated 3 on May 07, 2004
Recall Number Z-0678-03
Recall Event ID 25499
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory,

Calculator/Data processing Module for Clinical Use (21 CFR 862.2100)

Misys Laboratory GUI Version 5.3
Code Information Version 5.3
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Cheryl Terpning
520-382-6218
Manufacturer Reason
for Recall		 Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
FDA Determined
Cause 2		 Other
Action Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready.
Quantity in Commerce 520
Distribution Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
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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