Foundation Medicine recalls

Foundation Medicine has 10 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 26 Aug 2026. 8 are still ongoing. 5 were reported in the last 12 months.

Total recalls10since 2018

Last 12 months5reported

Class I00% of total

Ongoing8latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 1 2 0Jul 0 0 0Oct 0 2 0Jan '26 0 0 2Apr 0 0 0Jul 1 0

Severity split

Class I 0 0%Class II 10 100%Class III 0 0%

Why foundation medicine is recalled

Other Reasons880%
Device Malfunction220%

Product types

By year

2026330%
2025550%
2019110%
2018110%

Ongoing foundation medicine recalls

8 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Hamilton Microlab STAR Liquid Handler recalled by Foundation Medicine	Foundation Medicine	Device Malfunction	Nationwide
29 Apr 2026Device	CLASS II	Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recalled	Foundation Medicine	Other	Nationwide
29 Apr 2026Device	CLASS II	Protocol Configuration Tool (PCT) recalled by Foundation Medicine	Foundation Medicine	Device Malfunction	MA, NC
3 Dec 2025Device	CLASS II	FoundationOne Liquid CDx (F1LCDx), Tech recalled by Foundation Medicine	Foundation Medicine	Other	Nationwide
3 Dec 2025Device	CLASS II	FoundationOne CDx (F1CDx), RAL recalled by Foundation Medicine	Foundation Medicine	Other	Nationwide
11 Jun 2025Device	CLASS II	FoundationOne Companion Diagnostic (F1CDx) recalled	Foundation Medicine	Other	Nationwide

All foundation medicine recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Hamilton Microlab STAR Liquid Handler recalled by Foundation Medicine	Foundation Medicine	Device Malfunction	Nationwide
29 Apr 2026Device	CLASS II	Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recalled	Foundation Medicine	Other	Nationwide
29 Apr 2026Device	CLASS II	Protocol Configuration Tool (PCT) recalled by Foundation Medicine	Foundation Medicine	Device Malfunction	MA, NC
3 Dec 2025Device	CLASS II	FoundationOne Liquid CDx (F1LCDx), Tech recalled by Foundation Medicine	Foundation Medicine	Other	Nationwide
3 Dec 2025Device	CLASS II	FoundationOne CDx (F1CDx), RAL recalled by Foundation Medicine	Foundation Medicine	Other	Nationwide
11 Jun 2025Device	CLASS II	FoundationOne Companion Diagnostic (F1CDx) recalled	Foundation Medicine	Other	Nationwide
11 Jun 2025Device	CLASS II	FoundationOne Companion Diagnostic (F1CDx) recalled	Foundation Medicine	Other	Nationwide
21 May 2025Device	CLASS II	FoundationOne Companion Diagnostic (F1CDx) recalled	Foundation Medicine	Other	Nationwide
4 Dec 2019Device	CLASS II	FoundationOne CDx test report recalled by Foundation Medicine	Foundation Medicine	Other	5 states
26 Dec 2018Device	CLASS II	FoundationOne CDx Test Results recalled by Foundation Medicine	Foundation Medicine	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.