FDA Device recall Z-0046-2020
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE by Leica Biosystems Imaging, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0046-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-10 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Leica Biosystems Imaging |
| Distribution | n/a |
Product
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Reason
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.
Identifiers
| code_info | Serial numbers 5899, 5902, and 5986. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0046-2020%22
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