| Class 2 Device Recall |  |
Date Initiated by Firm | March 26, 2003 |
Date Posted | May 08, 2003 |
Recall Status1 |
Terminated 3 on April 21, 2004 |
Recall Number | Z-0791-03 |
Recall Event ID |
25993 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product | Misys Laboratory System versions 5.23 and 5.3 |
Code Information |
Versions 5.23 and 5.3 |
Recalling Firm/ Manufacturer |
Misys Healthcare Systems 4801 E Broadway Blvd Tucson AZ 85711
|
For Additional Information Contact | Mark Ellis 520-570-2000 |
Manufacturer Reason for Recall | With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests. |
FDA Determined Cause 2 | Other |
Action | The firm faxed notification on 3/26/2003 along with a response form and a temporary procedural workaround in Product Safety Notice PSN-03-L13. |
Quantity in Commerce | 463 |
Distribution | Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates. |
Total Product Life Cycle | TPLC Device Report |
|
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.
|
|
|
|