Foundation Medicine, Inc.
Complete recall history across all FDA and CPSC categories — 7 total recalls
Foundation Medicine, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (7)
FDA medical device enforcement actions by Foundation Medicine, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 9, 2025 | FoundationOne Companion Diagnostic (F1CDx) | Four (4) total reports were sent to customers with clinically relevant varian... | Class II |
| Jun 18, 2024 | FoundationOne Companion Diagnostic (F1CDx) | Two (2) reports were sent to customers with an incorrect negative claim on th... | Class II |
| Feb 15, 2023 | FoundationOne Companion Diagnostic (F1CDx) | An incorrect negative claim was identified on the claims page; the device var... | Class II |
| Nov 8, 2022 | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims ... | Class II |
| Nov 8, 2022 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims ... | Class II |
| Aug 8, 2019 | FoundationOne CDx test report | Identified potential false positive MSI-H on the test reports provided to the... | Class II |
| Oct 31, 2018 | FoundationOne CDx Test Results | An incorrect test result for a single analyte may have been reported for up t... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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