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Leica Microsystems, Inc. recalls BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Poly
Recalled December 18, 2019 · FDA recall Z-0673-2020 · Leica Microsystems
Hazard
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. · FDA Class II
Units
558
Sold at
Nationwide and OUS to Canada.
Description
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
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.
Manufacturer(s)
Leica Microsystems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →