CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
Hamilton Microlab STAR Liquid Handler recalled by Foundation Medicine
Foundation Medicine is recalling Hamilton Microlab STAR Liquid Handler, distributed nationwide in the US. The recall was initiated on 10 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2951-2026
- FDA event ID
- 99268
- Recalling firm
- Foundation Medicine, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +65 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issue that can cause an increase in spontaneous software closures.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Where it was distributed
US Nationwide distribution in the states of MA & NC.
Questions about this recall
Why was it recalled?
Software issue that can cause an increase in spontaneous software closures.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of MA & NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Foundation Medicine
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recalled | Foundation Medicine | Other | Nationwide |
| Device | CLASS II | Protocol Configuration Tool (PCT) recalled by Foundation Medicine | Foundation Medicine | Device Malfunction | MA, NC |
| Device | CLASS II | FoundationOne Liquid CDx (F1LCDx), Tech recalled by Foundation Medicine | Foundation Medicine | Other | Nationwide |
| Device | CLASS II | FoundationOne CDx (F1CDx), RAL recalled by Foundation Medicine | Foundation Medicine | Other | Nationwide |
| Device | CLASS II | FoundationOne Companion Diagnostic (F1CDx) recalled | Foundation Medicine | Other | Nationwide |
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