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U.S. Department of Health and Human Services

Class 2 Device Recall Tecan Genesis Instruments

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  Class 2 Device Recall Tecan Genesis Instruments see related information
Date Initiated by Firm February 27, 2003
Date Posted May 29, 2003
Recall Status1 Terminated 3 on April 06, 2006
Recall Number Z-0869-03
Recall Event ID 25850
510(K)Number K953345  
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
Product Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
Code Information Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower
Recalling Firm/
Manufacturer
Tecan U S Inc
4022 Stirrup Creek Rd,Ste310
Durham NC 27709
For Additional Information Contact Ron Wheeler
919-361-5200 Ext. 509
Manufacturer Reason
for Recall
Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.
FDA Determined
Cause 2
Other
Action Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade.
Quantity in Commerce 327 instruments require firmware upgrade.
Distribution Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
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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