Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended u...

FDA Device Recall #Z-0064-2019 — Class II — June 13, 2018

Recall Summary

Recall Number Z-0064-2019
Classification Class II — Moderate risk
Date Initiated June 13, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Leica Microsystems, Inc.
Location Buffalo Grove, IL
Product Type Devices
Quantity 67 units

Product Description

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 Pattern

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

Lot / Code Information

Serial Numbers: 70-78, 111-112, 120-175

Other Recalls from Leica Microsystems, Inc.

Recall # Classification Product Date
Z-0477-2023 Class II Leica MICROSYSTEMS M530 OHX, Part Number 104487... Nov 21, 2022
Z-0476-2023 Class II Leica MICROSYSTEMS Provido, Part Numbers 104489... Nov 21, 2022
Z-0475-2023 Class II Leica MICROSYSTEMS Proveo 8, Part Number 104490... Nov 21, 2022
Z-1849-2022 Class II Leica Surgical Operating Microscopes, Arveo, Pa... Aug 26, 2022
Z-1848-2022 Class II Leica Surgical Operating Microscopes, ARveo 8, ... Aug 26, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.