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Class 3 Device Recall |
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Date Initiated by Firm |
December 20, 2002 |
Date Posted |
January 30, 2003 |
Recall Status1 |
Terminated 3 on December 01, 2004 |
Recall Number |
Z-0495-03 |
Recall Event ID |
25378 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
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Product |
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 |
Mark Ellis 520-570-3609
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Manufacturer Reason for Recall |
An incorrect collection date and time may be accepted and filed to the patient file.
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FDA Determined Cause 2 |
Other |
Action |
The 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 Commerce |
465 |
Distribution |
Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates. |
Total Product Life Cycle |
TPLC Device Report
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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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