# FDA recall Z-0535-2020

> **Foundation Medicine, Inc.** · Class II · device recall initiated 2019-08-08.

## Product

FoundationOne CDx test report

## Reason for recall

Identified potential false positive MSI-H on the test reports provided to the physicians.

## Distribution

MA, NC,IN, OH, GA

## Key facts

- **Recall number:** Z-0535-2020
- **Recalling firm:** Foundation Medicine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-08
- **Report date:** 2019-12-04
- **Termination date:** 2021-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2020

## Citation

> AI Analytics. FDA recall Z-0535-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0535-2020. Source: US FDA. Licensed CC0.

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