United StatesProtocol Configuration Tool (PCT) software v1.3.0 for the Hamilton AutoLys STAR used within the FoundationOneCDx (F1CDx) system is affected; affected installations are at Foundation Medicine’s Research Triangle Park laboratory on equipment IDs 01342, 01591, 01989, 01990, 01994, and 01995 (10 units distributed in North Carolina and Massachusetts). It was recalled because the PCT deployment can cause spontaneous closures of the Hamilton HxRunControl software during execution of AutoLys protocols.
What's being recalled
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.
Recalling firm: Foundation Medicine, Inc., Cambridge, MA, United States.
How to identify it
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
The hazard
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to North Carolina and Massachusetts.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)