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Foundation Medicine, Inc.

Country not established FDA establishment FEI 3010679023

Devices
5
Registrations
FDA
FDA recalls
108 ongoing

Catalogue5

Newest first, rows 1-5 of 5

Company details

FDA FEI number
3010679023
Address
150 Second St, Cambridge, MA, 02141

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 2
  • 2023 1
  • 2024 1
  • 2025 1
  • 2026 3

  • 2026

    • 10 Jun 2026 Z-2951-2026 Class II Ongoing Software issue that can cause an increase in spontaneous software closures. Distribution: US Nationwide distribution in the states of MA & NC. Submission numbers: P200006, P170019
    • 24 Mar 2026 Z-1937-2026 Class II Ongoing Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. Distribution: US distribution to North Carolina and Massachusetts. Submission number: P170019
    • 20 Mar 2026 Z-1927-2026 Class II Ongoing Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants Distribution: US Nationwide distribution in the states of Massachusetts and North Carolina. Submission number: P170019

  • 2025

    • 9 Apr 2025 Z-1747-2025 Class II Ongoing 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. Submission number: P170019

  • 2024

    • 18 Jun 2024 Z-1890-2025 Class II Ongoing Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports. Distribution: US Nationwide distribution in the state of MI. Submission number: P170019

  • 2023

    • 15 Feb 2023 Z-1891-2025 Class II Ongoing An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. Distribution: US Nationwide distribution in the state of WI. Submission number: P170019

  • 2022

    • 8 Nov 2022 Z-0577-2026 Class II Ongoing 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. 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,…
      Full distribution text 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, Singapore.
      Submission number: P170019
    • 8 Nov 2022 Z-0578-2026 Class II Ongoing 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. 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,…
      Full distribution text 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, Singapore.
      Submission number: P200006

  • 2019

    • 8 Aug 2019 Z-0535-2020 Class II Terminated Identified potential false positive MSI-H on the test reports provided to the physicians. Distribution: MA, NC,IN, OH, GA Submission number: P170019

  • 2018

    • 31 Oct 2018 Z-0649-2019 Class II Terminated An incorrect test result for a single analyte may have been reported for up to 800 physician reports Distribution: US nationwide Submission number: P170019

Frequently asked questions

How many devices does FOUNDATION MEDICINE, INC. have in the registry?

The registry currently lists 5 devices for FOUNDATION MEDICINE, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list FOUNDATION MEDICINE, INC.'s devices?

Among its 5 most recently registered devices, FOUNDATION MEDICINE, INC. has devices listed in FDA PMA (5 devices).

What risk classes do FOUNDATION MEDICINE, INC.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for FOUNDATION MEDICINE, INC.'s devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for FOUNDATION MEDICINE, INC.?

FDA recall records list 10 recalls initiated by FOUNDATION MEDICINE, INC., the most recent initiated on 2026-06-10. 8 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from FOUNDATION MEDICINE, INC. in the registry?

The most recently registered devices listed for FOUNDATION MEDICINE, INC. include FoundationFocus CDxBRCA, FoundationOne Liquid CDx, FoundationOne CDx, FoundationOne Liquid CDx and FoundationOne Liquid CDx (F1 Liquid CDx).

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.