Device recall: FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Class II FDA enforcement event 97854. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Class II, in the words of FDA
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
Foundation Medicine, Inc. started this device recall on 8 Nov 2022. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class II. FDA event 97854 has 2 product records. The first FDA enforcement report date is 3 Dec 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan,…
Recalling firm
Foundation Medicine, Inc., Cambridge, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0577-2026 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | 59 units (39 US, 20 OUS) | Class II | Ongoing | 3 Dec 2025 |
| Z-0578-2026 | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 | 18 units (17 US, 1 OUS) | Class II | Ongoing | 3 Dec 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 9
Other events of the firm
| 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 |
| 9 Apr 2025 | FoundationOne Companion Diagnostic (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 Aug 2019 | FoundationOne CDx test report | Device | Class II | 1 |
| 31 Oct 2018 | FoundationOne CDx Test Results | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0577-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 97854. https://recallregister.com/fda/ii/97854/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan,…
- What quantity of product is in FDA event 97854?
- The event has 2 product records. The first record gives this quantity:
59 units (39 US, 20 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.