Recall Z-0673-2020
Leica Microsystems, Inc. · initiated November 18, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot: 65549
Reason for recall
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
FDA-determined cause: Environmental control
Action taken
Customers were notified with an Urgent Medical Device recall letter beginning 11/18/2019. The letter identified affected product, stated reason for recall, requested that product not be used and to dispose of any product on hand. A response form was asked to be completed and returned. Questions can be directed to Adam Blunier at 1-847-821-3462 or adam.blunier@leicabiosystems.com.
Details
- Recall number
- Z-0673-2020
- Initiated
- November 18, 2019
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 558
- Distribution
- Nationwide and OUS to Canada.
- Recalling firm
- Leica Microsystems, Inc., Buffalo Grove, IL