FDAFDA recall Z-2951-2026 · Aug 26, 2026
Foundation Medicine, Inc.: Hamilton Microlab STAR Liquid Handler recall
Recall found
Product
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Reason for recall
Software issue that can cause an increase in spontaneous software closures.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 32 units
- Distribution
- US Nationwide distribution in the states of MA & NC.
- Recalling firm
- Foundation Medicine, Inc., Cambridge, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-10
Source: openFDA enforcement record Z-2951-2026 · search recall number Z-2951-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.