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
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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
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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 |
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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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