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U.S. Department of Health and Human Services

Class 1 Device Recall Tecan Genesis

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  Class 1 Device Recall Tecan Genesis see related information
Date Initiated by Firm May 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = TECAN U.S., INC.
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