FDA Device recall Z-0673-2020
BOND Polymer Refine Detection Kit, Catalog No. DS9800
- FDA Device
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of BOND Polymer Refine Detection Kit, Catalog No. DS9800 by Leica Microsystems, citing BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0673-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-18 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Leica Microsystems |
| Distribution | US |
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
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Identifiers
| code_info | Lot: 65549 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0673-2020%22
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