Class 1 Device Recall Tecan Genesis

• Date Initiated by Firm: May 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 17, 2005
• Recall Number: Z-1022-04
• Recall Event ID: 29238
• 510(K)Number: K953345
• Product Classification: Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
• Product: Tecan Clinical Workstations with Robonet software
• Code Information: PN 10-410 Tecan Genesis 150/8 Back End Configuration, PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
• Recalling Firm/ Manufacturer: Tecan U S Inc; 4022 Stirrup Creek Rd,Ste310; Durham NC 27709
• For Additional Information Contact: Tecan Technical Support; 800-338-3226
• Manufacturer Reason for Recall: Tecan software has the potential to match the patient with a different patient's test results.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on May 3, 2004
• Quantity in Commerce: 44 units (hardware), 33 units (software)
• Distribution: CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.
• 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