Date Initiated by Firm |
October 24, 2002 |
Date Posted |
December 11, 2002 |
Recall Status1 |
Terminated 3 on February 26, 2013 |
Recall Number |
Z-0325-03 |
Recall Event ID |
25077 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product |
Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus.
|
Code Information |
Versions 5.2, 5.23 and 5.3 with ADT Interface to CoPathPlus. |
Recalling Firm/ Manufacturer |
Sunquest Information Systems 4801 E Broadway Blvd Tucson AZ 85711
|
For Additional Information Contact |
Mark Ellis 520-570-2000
|
Manufacturer Reason for Recall |
Interfacing software systems have inconsistent character recognition characteristics.
|
FDA Determined Cause 2 |
Other |
Action |
A recall notice was sent to hospitals on October 24, 2002. It communicated a temporary procedure to work around the problem. Also mentioned was the availabllity of a utility to detect and report suspected duplicate Medical Record Numbers. |
Quantity in Commerce |
190 |
Distribution |
Nationwide and to Denmark, Bermuda, United Kingdom, Saudi Arabia, Canada. |
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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