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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 Instrumentssee related information
Date Initiated by FirmFebruary 27, 2003
Date PostedMay 29, 2003
Recall Status1 Terminated 3 on April 06, 2006
Recall NumberZ-0869-03
Recall Event ID 25850
510(K)NumberK953345 
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
ProductTecan 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 ContactRon 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
ActionTecan 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 Commerce327 instruments require firmware upgrade.
DistributionInstruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JQW
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