BOND Polymer Refine Detection Kit — Class II medical device recall Z-0673-2020
Ongoing recall by Leica Microsystems, Inc., reported 2019-12-18, distributed nationwide. BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which
| Recall number | Z-0673-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2019-11-18 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 558 |
| Lot numbers | 65549 |
| Model numbers | DS9800 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0673-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.