Class 2 Device Recall Aperio CS2 CE IVD

• Date Initiated by Firm: December 10, 2018
• Date Posted: October 04, 2019
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-0046-2020
• Recall Event ID: 83383
• 510(K)Number: K141109
• Product Classification: Microscope, automated, image analysis, operator intervention - Product Code NOT
• Product: Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
• Code Information: Serial numbers 5899, 5902, and 5986.
• FEI Number: 3006791373
• Recalling Firm/ Manufacturer: Leica Biosystems Imaging, Inc.; 1360 Park Center Dr; Vista CA 92081-8300
• For Additional Information Contact: Robert Browning; 760-304-6211
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: The consignees were notified beginning on 12/10/2018 via letter delivered by email.
• Quantity in Commerce: 3 devices
• Distribution: There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NOT