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U.S. Department of Health and Human Services

Class 2 Device Recall Aperio CS2 CE IVD

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  Class 2 Device Recall Aperio CS2 CE IVD see related information
Date Initiated by Firm December 10, 2018
Date Posted October 04, 2019
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = LEICA BIOSYSTEMS IMAGING, INC.
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