Vista, CA, United States
Leica Biosystems Imaging, Inc. recalls
1 recall recorded since 2018, most recently on 10 December 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 December 2018
- Terminated
- 28 April 2021
- 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.
- Distribution
- There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0046-2020
- Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.