| Class 2 Device Recall |  |
Date Initiated by Firm | June 10, 2003 |
Date Posted | July 15, 2003 |
Recall Status1 |
Terminated 3 on April 23, 2004 |
Recall Number | Z-1007-03 |
Recall Event ID |
26541 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product | Misys Laboratory System, versions 5.2, 5.23 and 5.3 |
Code Information |
Versions 5.2, 5.23 and 5.3 |
Recalling Firm/ Manufacturer |
Misys Healthcare Systems 4801 E Broadway Blvd Tucson AZ 85711
|
For Additional Information Contact | Barbara Brown 520-570-2000 |
Manufacturer Reason for Recall | Software anomally
Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations. |
FDA Determined Cause 2 | Other |
Action | Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality. |
Quantity in Commerce | 467 |
Distribution | Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, 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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