uPath software 1 — Class II medical device recall Z-0877-2021
Terminated recall by Roche Molecular Systems, Inc., reported 2021-01-27, distributed in MD, MI. When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measuremen
| Recall number | Z-0877-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2020-11-23 |
| Classified | 2021-01-16 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2023-05-22 |
| Distributed | MD, MI |
| Countries outside the US | BR, FR, GR, IN, IT, PL, SG, TR |
| Quantity | 27 |
| Reason classes | software |
Product
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0877-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.