FDA recall, , Moderate risk
Foundation Medicine Hamilton Microlab STAR Liquid Handler
The Hamilton Microlab STAR Liquid Handler has a software issue that can cause spontaneous software closures.
Summary by Recall Canary from the FDA notice
What happened
Foundation Medicine, Inc., of Cambridge, Massachusetts, recalled the Hamilton Microlab STAR Liquid Handler with Protocol Configuration Tool (PCT) v2.0.0, used to conduct F1CDx and F1LCDx. The recall began on June 10, 2026, and was added to the FDA's Enforcement Report on August 14, 2026. The software issue can cause an increase in spontaneous software closures. The 32 units were distributed 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.
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- Affected units
- Software Version: Protocol Configuration Tool (PCT) v2.0.0; Equipment ID: 100071, 100213, 100355, 102281, 103047, 104154, 104201, 104202, 104204, 104205, 104224, 104503, 104504, 104562, 104885, 105961, 106497, 00016, 00487, 00488, 00489, 00490, 00817, 00491, 00492, 00854, 01173, 01174, 01785, 01337, 01596, 01993.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Massachusetts & North Carolina.
- 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
- 99268
- Recall number
- Z-2951-2026
- Quantity recalled
- 32 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
