medical Class II Updated 2019-12-18

Leica Microsystems, Inc. recalls BOND Polymer Refine Detection Kit, Catalog No. DS9800. This

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 65549
View official government recall

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