Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
This recall has been terminated (originally issued October 4, 2019).
- Company
- Leica Biosystems Imaging, Inc.
- Recall Initiated
- December 10, 2018
- Posted
- October 4, 2019
- Terminated
- April 28, 2021
- Recall Number
- Z-0046-2020
- Quantity
- 3 devices
- Firm Location
- Vista, CA
- Official Source
- View on FDA website ↗
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
There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
Lot / Code Info
Serial numbers 5899, 5902, and 5986.
Root Cause
Component design/selection
Action Taken
The consignees were notified beginning on 12/10/2018 via letter delivered by email.