medical Class II Updated 2019-10-16

Leica Biosystems Imaging, Inc. recalls Aperio CS2 CE IVD scanner instrument, scanner part #23CS100C

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

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.
View official government recall

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