FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
- Recall number
- Z-0877-2021
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
- Status
- Terminated
- Initiated
- 2020-11-23
- Posted
- not on file
- Terminated
- 2023-05-22
- Reason
- 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.
- Root cause
- 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
- 27
- Distribution
- Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
- Lot, serial or model codes
- version 1.1
- 510(k) numbers
- ["K140465"]
- PMA numbers
- not on file
- Product code
- NQN
- Firm FEI
- 2243471
- Firm city
- S Branchburg
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28