Z-0046-2020 Class II Terminated
FDA device recall Z-0046-2020 was initiated by Leica Biosystems Imaging, Inc. on December 10, 2018 and is designated Class II. 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 i… The recall status is terminated (terminated April 28, 2021). Affected quantity: 3 devices.
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.