Recall Z-0673-2020 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
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
| Date | Nov 18, 2019 |
| Status | Open, Classified |
| Reason | BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. |
| Root cause | Environmental control |
| Action | 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. |
| Quantity | 558 |
| Distribution | Nationwide and OUS to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.