FDA recall Z-0673-2020

Leica Microsystems, Inc. · Class II · device

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.

Reason for recall

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

Distribution

Nationwide and OUS to Canada.

Key facts

Status
Ongoing
Initiation date
2019-11-18
Report date
2019-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0673-2020