| |
Class 2 Device Recall |
 |
| Date Initiated by Firm |
February 06, 2003 |
| Date Posted |
March 13, 2003 |
| Recall Status1 |
Terminated 3 on May 07, 2004 |
| Recall Number |
Z-0646-03 |
| Recall Event ID |
25641 |
| Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
| Product |
Misys 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 |
Mark Ellis
520-570-2000
|
Manufacturer Reason
for Recall |
Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
|
FDA Determined
Cause 2 |
Other |
| Action |
Firm notified customers by fax on 2/6/2003. This included a workaround procedure. A correcting software package will be created and announced at a later date. Estimated completion date is May 1, 2003 |
| Quantity in Commerce |
465 |
| 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.
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