Leica Biosystems Imaging, Inc. recalls Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
- Recall date
- December 10, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0046-2020
- FDA classification
- Class II
- Brand / firm
- Leica Biosystems Imaging, Inc.
- Sold / distributed
- There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
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