Date Initiated by Firm | January 31, 2003 |
Date Posted | March 06, 2003 |
Recall Status1 |
Terminated 3 on May 07, 2004 |
Recall Number | Z-0614-03 |
Recall Event ID |
25556 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
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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
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For Additional Information Contact | Mark Ellis 520-733-6403 |
Manufacturer Reason for Recall | Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected. |
FDA Determined Cause 2 | Other |
Action | Firm sent notice by FAX on 1/31/2003. A workaround provided should prevent the problem until a software fix is made available. Clients can expect a notice when this is made available. |
Quantity in Commerce | 542 |
Distribution | Nationwide and to United Kingdom, Canada, Denmark, Ireland, 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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