Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0326-06

Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series * Order Number...

Tecan U.S. / initiated 2005-04-11 / Terminated

Tecan U S Inc began a recall of Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestrae 103, CH-8708... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0326-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Tecan U.S.
Product
Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestrae 103, CH-8708 Mannedorf, Switzerland * Made in Germany. Blister 1 x 96 pcs.
Product code
JQW Station, Pipetting And Diluting, For Clinical Use
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 root cause
Other
Action
The consignee was notified via fax''d letter on/about 11/08/2005.
Quantity in commerce
3000 Tips
Distribution
IL and Europe
Product codes and lots
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.