Home / Recalls / Leica Biosystems Imaging, Inc. / Z-0046-2020

Z-0046-2020 Class II Terminated

Recalled by Leica Biosystems Imaging, Inc. — Vista, CA

Recall Details

Product Type: Devices
Report Date: October 16, 2019
Initiation Date: December 10, 2018
Termination Date: April 28, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 devices

Product Description

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

Reason for Recall

The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.

Distribution Pattern

There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.

Code Information

Serial numbers 5899, 5902, and 5986.