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U.S. Department of Health and Human Services

Class 2 Device Recall Bond Polymer Refine Detection

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  Class 2 Device Recall Bond Polymer Refine Detection see related information
Date Initiated by Firm November 16, 2010
Date Posted February 09, 2011
Recall Status1 Terminated 3 on October 17, 2011
Recall Number Z-1065-2011
Recall Event ID 57333
Product Classification Immunohistochemistry Reagents and Kits - Product Code NJT
Product Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800;
Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom.

Intended for immunohistochemistry on paraffin-embedded tissue sections.
Code Information Lot numbers 11279, 11297, 11315, 111604, 11693, and 11967.
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
2345 Waukegan Rd
Bannockburn IL 60015-1515
For Additional Information Contact Ms. M. Elizabeth Culotta
847-405-6565
Manufacturer Reason
for Recall		 Users of the Bond Polymer Refine Detection System, DS9800, may experience instances of "weak staining" due to the DAB Part B component, which may give a false negative result.
FDA Determined
Cause 2		 Other
Action Leica Microsystems sent Medical Device Field Correction letters dated 11/16/10 to the affected users of the Bond Polymer Refine Detection System, DS9800 via first class mail on the same date, informing them that they may experience instances of "weak staining" due to the DAB Part B component in the affected lots, which may give a false negative result. The users were requested to test their DS9800 System prior to use to rule out that the DAB Part B components have been affected, using the enclosed testing protocol. If their system is affected, the users were instructed not to use it and contact Leica Technical Assistance Center for a replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.
Quantity in Commerce 653 units
Distribution Worldwide Distribution -- USA and Canada.
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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