Z-0064-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- June 13, 2018
- Termination Date
- March 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code Information
Serial Numbers: 70-78, 111-112, 120-175