# FDA recall Z-0673-2020

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2019-11-18.

## 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

- **Recall number:** Z-0673-2020
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0673-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-0673-2020. Source: US FDA. Licensed CC0.

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