FDA Medical devices recall ·
Hamilton Microlab STAR Liquid Handler recall
- Recall number
- Z-2951-2026
- Date
- (initiated June 10, 2026)
- Company / brand
- Foundation Medicine, Inc.
150 2nd St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Why was it recalled?
Software issue that can cause an increase in spontaneous software closures.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution in the states of MA & NC.
States: North Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2951-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.