FDA Recall of FoundationOneCDx Software by Foundation Medicine
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Foundation Medicine, Inc. is voluntarily recalling 10 units of Protocol Configuration Tool software due to potential spontaneous closures during operation, affecting devices in North Carolina and Massachusetts.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States, specifically North Carolina and Massachusetts. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
Recall Article
What Happened
Foundation Medicine, Inc. is recalling the Protocol Configuration Tool (PCT) software due to the potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment.
Which Products Are Affected
The affected products are the Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx), installed on Equipment IDs: 01342, 01591, 01989, 01990, 01994, and 01995. A total of 10 units are affected, with distribution to North Carolina and Massachusetts. The recall number is Z-1937-2026.
What You Should Do
Consumers should contact the recalling firm, Foundation Medicine, Inc., at their address: 150 2nd St, Cambridge, MA 02141-2115, as the recall was initiated via E-Mail.
Why This Matters
This recall involves medical devices that could disrupt laboratory operations, potentially affecting testing accuracy in the specified regions.
Source
FDA Recall Notice Z-1937-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,026 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.