FDA-Device2019-10-16Class II
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Leica Biosystems Imaging, Inc.
Hazard
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.
Sold states
There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
Affected count
3 devices
Manufactured in
1360 Park Center Dr, N/A, Vista, CA, United States
Products
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0046-2020Don't want to check this manually?
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