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Class 1 Device Recall |
 |
| Date Initiated by Firm |
May 05, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on July 24, 2007 |
| Recall Number |
Z-0999-04 |
| Recall Event ID |
29060 |
| Product Classification |
Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
|
| Product |
Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001. |
| Code Information |
All units (serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615). |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
800-526-1247
|
Manufacturer Reason
for Recall |
Tecan software has the potential to match the patient with a different patient's test results.
|
FDA Determined
Cause 2 |
Other |
| Action |
Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories. |
| Quantity in Commerce |
11 |
| Distribution |
Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, Texas and Wisconsin. |
| 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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