Foundation Medicine recalls AutoLys STAR PCT software v1.3.0 for spontaneous software
Foundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR used in FoundationOneCDx. Potential for spontaneous software closures during autolys protocols after deployment.
Lower-risk recall
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Contact the company
What happened, in plain English
Foundation Medicine recalls a specific software version for their AutoLys STAR system used in FoundationOneCDx testing. This software version may close unexpectedly during lab protocols, which could disrupt critical cancer testing processes. Read more at govinfonow.com/recall/49633-foundation-medicine-recalls-autolys-star-pct-software-v1-3-0.
Source Summary by GovInfoNow · govinfonow.com/recall/49633-foundation-medicine-recalls-autolys-star-pct-software-v1-3-0 · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1937-2026
Cite this page
“Foundation Medicine recalls AutoLys STAR PCT software v1.3.0 for spontaneous software.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49633-foundation-medicine-recalls-autolys-star-pct-software-v1-3-0. Based on FDA recall #Z-1937-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1937-2026%22&limit=1).
Why it’s dangerous
The PCT software v1.3.0 may close unexpectedly during autolys protocols. This could interrupt cancer testing workflows and potentially lead to incomplete results. The hazard occurs after the software is deployed for the AutoLys STAR system.
Who’s affected
Researchers using FoundationOneCDx cancer testing with the affected software version. Lab technicians handling the AutoLys STAR system are most at risk of protocol interruptions.
How to tell if you have this one
Check if you have the PCT software version 1.3.0 installed on Hamilton AutoLys STAR systems used with FoundationOneCDx. The affected equipment has specific Research Triangle Park laboratory IDs: 01342, 01591, 01989, 01990, 01994, 01995.
- Brand
Foundation Medicine- Category
Medical device
What to do — step by step
Check Software Version
Verify if your Hamilton AutoLys STAR system has PCT software version 1.3.0 installed for FoundationOneCDx use.
Where it went and when
Where it was distributed
Distributed in Massachusetts and North Carolina.
FDA distribution: “US distribution to North Carolina and Massachusetts.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts, North Carolina.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1937-2026 (March 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1937-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.