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Leica Biosystems Imaging, Inc. recalls Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Recalled October 16, 2019 · FDA recall Z-0046-2020 · Leica Biosystems Imaging
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. · FDA Class II
Units
3 devices
Sold at
There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
Description
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.
Product
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Manufacturer(s)
Leica Biosystems Imaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →