# FDA recall Z-0064-2019

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2018-06-13.

## Product

Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated    Product Usage:  The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.

## Reason for recall

These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.

## Distribution

Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI.      Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND

## Key facts

- **Recall number:** Z-0064-2019
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-13
- **Report date:** 2018-10-10
- **Termination date:** 2019-03-18

- **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-0064-2019

## Citation

> AI Analytics. FDA recall Z-0064-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0064-2019. Source: US FDA. Licensed CC0.

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