Protocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The source text describes a potential software malfunction without any evidence of harm to patients or users, making it a moderate-severity recall.
Plain-English summary
Foundation Medicine, Inc. is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx installed on laboratory equipment in Research Triangle Park (Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995). The software has the potential to cause spontaneous closures of Hamilton HxRunControl software during the execution of AutoLys protocols after the PCT software is deployed.
The recall affects 10 units distributed to laboratories in North Carolina and Massachusetts. Users of this software should discontinue use of the affected version and contact Foundation Medicine for updated software or additional guidance.
The recalled product
- Product
- Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
- Manufacturer
- Foundation Medicine, Inc.
- Affected units
- 10
Distribution
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