Foundation Medicine, Inc.
Foundation Medicine, Inc. has 9 FDA enforcement events on this register (10 product records) between 2018 and 2026: 9 device; the busiest year was 2026 with 3.
0% of its events are Class I; the most common class is Class II (9). 7 events are listed as ongoing; the recalling firm's address is in MA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 10 Jun 2026 | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. | Device | Class II | 1 | Ongoing |
| 24 Mar 2026 | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995. | Device | Class II | 1 | Ongoing |
| 20 Mar 2026 | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Device | Class II | 1 | Ongoing |
| 9 Apr 2025 | FoundationOne Companion Diagnostic (F1CDx) | Device | Class II | 1 | Ongoing |
| 18 Jun 2024 | FoundationOne Companion Diagnostic (F1CDx) | Device | Class II | 1 | Ongoing |
| 15 Feb 2023 | FoundationOne Companion Diagnostic (F1CDx) | Device | Class II | 1 | Ongoing |
| 8 Nov 2022 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Device | Class II | 2 | Ongoing |
| 8 Aug 2019 | FoundationOne CDx test report | Device | Class II | 1 | Terminated |
| 31 Oct 2018 | FoundationOne CDx Test Results | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Foundation Medicine, Inc. had?
9 enforcement events (10 product records) on this register, 2018–2026: 9 device.
Are any Foundation Medicine, Inc. recalls ongoing?
7 events are listed as ongoing in the current openFDA export.
What class are Foundation Medicine, Inc. recalls?
9 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.