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Class 1 Device Recall Tecan Genesis |
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Date Initiated by Firm |
March 05, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on August 07, 2007 |
Recall Number |
Z-0996-04 |
Recall Event ID |
28984 |
510(K)Number |
K953345
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Product Classification |
Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
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Product |
Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. |
Code Information |
Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724. |
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 |
If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.
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FDA Determined Cause 2 |
Other |
Action |
Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04. |
Quantity in Commerce |
14 |
Distribution |
Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, 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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510(K) Database |
510(K)s with Product Code = JQW and Original Applicant = TECAN U.S., INC.
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