FDA recall, , Moderate risk
Protocol Configuration Tool (PCT) Software v1.3.0 for Hamilton AutoLys STAR
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Summary by Recall Canary from the FDA notice
What happened
Foundation Medicine, Inc. of Cambridge, Massachusetts 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. The FDA added the recall to its Enforcement Report on April 23, 2026. The company began the recall on March 24, 2026, and the recall involves 10 units in Massachusetts and North Carolina.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are 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.
- Affected units
- Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
Recall details
- Company began the recall
- Sold in
- Company
- Foundation Medicine, Inc.Cambridge, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98640
- Recall number
- Z-1937-2026
- Quantity recalled
- 10 units
All recalls from Foundation Medicine, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated