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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Tips (Diti), Conductive, with Filter, 1000l

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  Class 2 Device Recall Disposable Tips (Diti), Conductive, with Filter, 1000l see related information
Date Initiated by Firm April 11, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 on May 18, 2006
Recall Number Z-0326-06
Recall Event ID 34159
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
Product Disposable Tips 1000 ¿l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestra¿e 103, CH-8708 Mannedorf, Switzerland * Made in Germany. Blister 1 x 96 pcs.
Code Information Part Number 10612523, Lot No. U122098L-1325, Lot No. U122098L-3225 & Lot No. U122098L-2325. The sub-lot numbers (i.e. 1325, 3225 and 2325) are printed on each blister and stamped in blue colour on the shipping container in the upper right corner of the box.  
Recalling Firm/
Manufacturer		 Tecan U S Inc
4022 Stirrup Creek Rd.
Research Triangle Park NC 27709
For Additional Information Contact Sereta Muse
919-638-1822
Manufacturer Reason
for Recall		 Double filtering of 1000 ¿l tips. The defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples.
FDA Determined
Cause 2		 Other
Action The consignee was notified via fax''d letter on/about 11/08/2005.
Quantity in Commerce 3000 Tips
Distribution IL and Europe
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.
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