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.
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
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.
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.
Researchers using FoundationOneCDx cancer testing with the affected software version. Lab technicians handling the AutoLys STAR system are most at risk of protocol interruptions.
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.
Verify if your Hamilton AutoLys STAR system has PCT software version 1.3.0 installed for FoundationOneCDx use.
The recall states potential for spontaneous software closures during autolys protocols, which could disrupt cancer testing. The hazard is not described as causing injury or serious harm.
Check if your Hamilton AutoLys STAR system has PCT software version 1.3.0 installed for FoundationOneCDx use. The affected equipment has specific Research Triangle Park laboratory IDs: 01342, 01591, 01989, 01990, 01994, 01995.
The recall does not specify a remedy. You should check if the software is causing issues and contact Foundation Medicine for guidance.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-1937-2026 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-1937-2026 from Foundation Medicine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
