Date Initiated by Firm |
March 19, 2003 |
Date Posted |
July 02, 2003 |
Recall Status1 |
Terminated 3 on December 01, 2004 |
Recall Number |
Z-0972-03 |
Recall Event ID |
26501 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product |
Mysys Laboratory System 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 |
Barbara Brown 520-733-6403
|
Manufacturer Reason for Recall |
Abnormal results are flagged as normal.
|
FDA Determined Cause 2 |
Other |
Action |
This is a completed recall. Consignee has had the software patch installed and reports it to be functional as of March 19, 2003. Recall notice was also sent that same day. |
Quantity in Commerce |
1 |
Distribution |
Only to one hospital in Nebraska. |
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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