Class 1 Device Recall Tecan Genesis

• Date Initiated by Firm: March 05, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 07, 2007
• Recall Number: Z-0996-04
• Recall Event ID: 28984
• 510(K)Number: K953345
• Product Classification: Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
• 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
• For Additional Information Contact: 800-526-1247
• Manufacturer Reason for Recall: If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.
• FDA Determined Cause: 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

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.

• 510(K) Database: 510(K)s with Product Code = JQW and Original Applicant = TECAN U.S., INC.