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.
This recall is currently active, issued November 18, 2019. It was issued by Leica Microsystems, Inc..
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- November 18, 2019
- Recall Number
- Z-0673-2020
- Quantity
- 558
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Distribution
Nationwide and OUS to Canada.
Lot / Code Info
Lot: 65549
Root Cause
Environmental control
Action Taken
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.