Aperio CS2 CE IVD scanner instrument recall
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Why was Aperio CS2 CE IVD scanner instrument 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers 5899, 5902, and 5986.
- Product
- Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
- Recalling firm
- Leica Biosystems Imaging, Inc.
- Quantity
- 3 devices
- Distribution
- There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)