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U.S. Department of Health and Human Services

Class 2 Device Recall uPath software 1.1

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  Class 2 Device Recall uPath software 1.1 see related information
Date Initiated by Firm November 23, 2020
Create Date January 17, 2021
Recall Status1 Terminated 3 on May 22, 2023
Recall Number Z-0877-2021
Recall Event ID 86996
510(K)Number K140465  
Product Classification Microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & perc - Product Code NQN
Product uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Code Information version 1.1
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact Roche Support Network Customer Support
800-227-2155
Manufacturer Reason
for Recall		 When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
FDA Determined
Cause 2		 Software design
Action On November 23, 2020, the firm initiated its recall. The firm distributed Urgent Medical Device Correction letters to affected customers using uPath software version 1.1 IVD. Until uPath Enterprise software version 1.1.1 patch is installed, customers using uPath Enterprise software version 1.1 should not analyze slides with different scan magnifications in Split View. In order to reduce the risk of this issue impacting patient care, customers should follow their local procedures and policies regarding retrospective re-review of cases. In particular, it is recommended that cases involving tumor measurements (e.g., melanoma, etc.) be considered for re-review, especially if the original diagnosis included a reported measurement (e.g., Breslow depth in melanoma, etc.). Pathologists need to assess the risk of this measurement error in the context of local pathology reporting processes and clinical decision making. Re-review should be limited to the following conditions, all of which are required for the issue to occur: 1. Slides were viewed in uPath Enterprise software version 1.1, 2. The tumor measurement was done in the Split View viewing mode, and 3. The slides within the Split View viewing mode were scanned at two different magnifications. Only under these conditions is a re-review and repeat tumor measurement recommended.
Quantity in Commerce 27
Distribution Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
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 = NQN and Original Applicant = VENTANA MEDICAL SYSTEMS, INC.
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