# FDA recall Z-0877-2021

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2020-11-23.

## 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.

## Distribution

Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.

## Key facts

- **Recall number:** Z-0877-2021
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-23
- **Report date:** 2021-01-27
- **Termination date:** 2023-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branchburg, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2021

## Citation

> AI Analytics. FDA recall Z-0877-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0877-2021. Source: US FDA. Licensed CC0.

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