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Class 1 Device Recall |
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Date Initiated by Firm |
May 05, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on July 24, 2007 |
Recall Number |
Z-1001-04 |
Recall Event ID |
29060 |
Product Classification |
Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
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Product |
Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001. |
Code Information |
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768). |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact |
800-526-1247
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Manufacturer Reason for Recall |
Tecan software has the potential to match the patient with a different patient's test results.
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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 |
8 |
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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