Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aperio CS2 CE IVD scanner instrument Recalled by Leica Biosystems Imaging, Inc. Due to The incorrect sensor was used in the assembly...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Leica Biosystems Imaging, Inc. directly.
Affected Products
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Quantity: 3 devices
Why Was This Recalled?
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.
Where Was This Sold?
There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
About Leica Biosystems Imaging, Inc.
Leica Biosystems Imaging, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report