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U.S. Department of Health and Human Services

Class 2 Device Recall BOND Polymer Refine Detection Kit

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  Class 2 Device Recall BOND Polymer Refine Detection Kit see related information
Date Initiated by Firm November 18, 2019
Create Date December 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-0673-2020
Recall Event ID 84301
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
Code Information Lot: 65549
Recalling Firm/
Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Adam Blunier
Manufacturer Reason
for Recall
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
FDA Determined
Cause 2
Environmental control
Action Customers were notified with an Urgent Medical Device recall letter beginning 11/18/2019. The letter identified affected product, stated reason for recall, requested that product not be used and to dispose of any product on hand. A response form was asked to be completed and returned. Questions can be directed to Adam Blunier at 1-847-821-3462 or adam.blunier@leicabiosystems.com.
Quantity in Commerce 558
Distribution Nationwide and OUS to 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.