Leica Microsystems, Inc. recalls BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polym…

Recall date

November 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0673-2020

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

Nationwide and OUS to Canada.

Why it was recalled

BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.