--- title: "Foundation Medicine, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Foundation Medicine, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/foundation-medicine-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Foundation Medicine, Inc. recall records **8** reported ongoing 8 records in this archive. Latest source date Jun 10, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 10, 2026 FDA device enforcement ### [Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.](https://isitonrecall.com/recall/fda-device-z-2951-2026-hamilton-microlab-star-liquid-handler-protocol-configuration-tool-pct-v2-0-0-used-to-conduct-f1cdx-a/) Software issue that can cause an increase in spontaneous software closures. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MA & NC. [Official source for Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2951-2026%22) Mar 24, 2026 FDA device enforcement ### [Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 013...](https://isitonrecall.com/recall/fda-device-z-1937-2026-protocol-configuration-tool-pct-software-v1-3-0-for-hamilton-autolys-star-used-within-foundationonec/) Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. Class II Reported ongoing Distribution: US distribution to North Carolina and Massachusetts. [Official source for Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within Foundatio...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1937-2026%22) Mar 20, 2026 FDA device enforcement ### [Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)](https://isitonrecall.com/recall/fda-device-z-1927-2026-sequencing-agent-seq0067-component-of-foundationone-cdx-f1cdx/) Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants Class II Reported ongoing Distribution: US Nationwide distribution in the states of Massachusetts and North Carolina. [Official source for Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1927-2026%22) Apr 9, 2025 FDA device enforcement ### [FoundationOne Companion Diagnostic (F1CDx)](https://isitonrecall.com/recall/fda-device-z-1747-2025-foundationone-companion-diagnostic-f1cdx/) 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. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia. [Official source for FoundationOne Companion Diagnostic (F1CDx)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1747-2025%22) Jun 18, 2024 FDA device enforcement ### [FoundationOne Companion Diagnostic (F1CDx)](https://isitonrecall.com/recall/fda-device-z-1890-2025-foundationone-companion-diagnostic-f1cdx/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the state of MI. [Official source for FoundationOne Companion Diagnostic (F1CDx)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1890-2025%22) Feb 15, 2023 FDA device enforcement ### [FoundationOne Companion Diagnostic (F1CDx)](https://isitonrecall.com/recall/fda-device-z-1891-2025-foundationone-companion-diagnostic-f1cdx/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the state of WI. [Official source for FoundationOne Companion Diagnostic (F1CDx)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1891-2025%22) Nov 8, 2022 FDA device enforcement ### [FoundationOne CDx (F1CDx), RAL-0003 version 31.0](https://isitonrecall.com/recall/fda-device-z-0577-2026-foundationone-cdx-f1cdx-ral-0003-version-31-0/) 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 Reported ongoing 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... [Official source for FoundationOne CDx (F1CDx), RAL-0003 version 31.0](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0577-2026%22) Nov 8, 2022 FDA device enforcement ### [FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0](https://isitonrecall.com/recall/fda-device-z-0578-2026-foundationone-liquid-cdx-f1lcdx-tech-0009-version-6-0/) 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 Reported ongoing 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... [Official source for FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0578-2026%22) ## Reasons in these listed records - Software issue that can cause an increase in spontaneous software closures. - Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. - Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Foundation Medicine, Inc. ### Is there a recall on foundation medicine, inc. right now? This archive contains 8 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Foundation Medicine, Inc.](https://isitonrecall.com/check/?q=Foundation%20Medicine%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)