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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/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Adam Blunier
847-821-3462
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.
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