Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install
Summary
The FDA issued a Class II for Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used by Foundation Medicine, Inc.. Reason: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for Au.
Details
Source
Device Recall
External ID
Z-1937-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
Quantity Affected: 10 units
Reason for Recall
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Distribution
US distribution to North Carolina and Massachusetts.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-24
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 217 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Foundation Medicine, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Foundation Medicine, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Foundation Medicine, Inc. have FDA actions?
Foundation Medicine, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1937-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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