Leica Microsystems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0673-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 18, 2019

Date Posted: December 18, 2019

Recall Number: Z-0673-2020

Event ID: 84301

Reason for Recall:

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

Status: Ongoing

Product Quantity: 558

Code Information:

Lot: 65549

Distribution Pattern:

Nationwide and OUS to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated