Product Wiki · Recalls · U.S. FDA — Device Enforcement

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. — recall Z-0046-2020

U.S. FDA — Device Enforcement · United States · 2018-12-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0046-2020
Date of alert
2018-12-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Leica Biosystems Imaging, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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