FDA recall Z-0046-2020

Product

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

Reason for recall

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.

Key facts

Status

Terminated

Initiation date

2018-12-10

Report date

2019-10-16

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vista, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0046-2020