Food, drugs, devices › Foundation Medicine, Inc.
Device recall: FoundationOne Companion Diagnostic (F1CDx)
FDA enforcement event 96621 is a device recall by Foundation Medicine, Inc. of Cambridge, MA, initiated 9 Apr 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Foundation Medicine, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Foundation Medicine, Inc., Cambridge, MA.
Reason for recall
"Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications."
Distribution
"Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1747-2025 | FoundationOne Companion Diagnostic (F1CDx) | 4 units | Class II | Ongoing | 21 May 2025 |
Context
Other enforcement events for Foundation Medicine, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 24 Mar 2026 | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install | Device | Class II | 1 |
| 20 Mar 2026 | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Device | Class II | 1 |
| 18 Jun 2024 | FoundationOne Companion Diagnostic (F1CDx) | Device | Class II | 1 |
| 15 Feb 2023 | FoundationOne Companion Diagnostic (F1CDx) | Device | Class II | 1 |
| 8 Nov 2022 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Device | Class II | 2 |
| 8 Aug 2019 | FoundationOne CDx test report | Device | Class II | 1 |
| 31 Oct 2018 | FoundationOne CDx Test Results | Device | Class II | 1 |
All 9 events for Foundation Medicine, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.