Cambridge, MA, United States
Foundation Medicine, Inc. recalls
9 recalls recorded since 2018, most recently on 10 June 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)7
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 June 2026
- Reason
- Software issue that can cause an increase in spontaneous software closures.
- Distribution
- US Nationwide distribution in the states of MA & NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2951-2026
- Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Ongoing Class II Medical devices
- Recall started
- 24 March 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1937-2026
- 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.
Ongoing Class II Medical devices
- Recall started
- 20 March 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1927-2026
- Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Ongoing Class II Medical devices
- Recall started
- 9 April 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1747-2025
- FoundationOne Companion Diagnostic (F1CDx)
Ongoing Class II Medical devices
- Recall started
- 18 June 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1890-2025
- FoundationOne Companion Diagnostic (F1CDx)
Ongoing Class II Medical devices
- Recall started
- 15 February 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1891-2025
- FoundationOne Companion Diagnostic (F1CDx)
Ongoing Class II Medical devices
- Recall started
- 8 November 2022
- Reason
- 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, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0577-2026, Z-0578-2026
- FoundationOne CDx (F1CDx), RAL-0003 version 31.0
- FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Terminated Class II Medical devices
- Recall started
- 8 August 2019
- Terminated
- 19 July 2021
- Reason
- Identified potential false positive MSI-H on the test reports provided to the physicians.
- Distribution
- MA, NC,IN, OH, GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0535-2020
- FoundationOne CDx test report
Terminated Class II Medical devices
- Recall started
- 31 October 2018
- Terminated
- 17 April 2020
- Reason
- An incorrect test result for a single analyte may have been reported for up to 800 physician reports
- Distribution
- US nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0649-2019
- FoundationOne CDx Test Results
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.