Leica Microsystems, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Leica Microsystems, Inc.
Lot Codes / Batch Numbers
Lot: 65549
Products Sold
Lot: 65549
Leica Microsystems, Inc. is recalling BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagno due to BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026