Reported Oct 16, 2019 · Terminated
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Leica Biosystems Imaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Biosystems Imaging, Inc. · 1360 Park Center Dr · Vista, CA · 92081-8300
Is this the product you have?
Aperio CS2 CE IVD scanner instrumentscanner part #23CS100CE
- Lot codes and dates
Serial numbers 58995902and 5986
- Amount recalled
- 3 devices
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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