Foundation Medicine recall: Hamilton Microlab STAR Liquid Handler
Foundation Medicine, Inc. is recalling Hamilton Microlab STAR Liquid Handler – 32 units. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on June 10, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Hamilton Microlab STAR Liquid Handler |
| Brand | Foundation Medicine |
| Company | Foundation Medicine, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | June 10, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 32 units |
| Recall ID | 99268 |
Recalled products
- Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- FDA recall number
- Z-2951-2026
- 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
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99268
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Cambridge, MA, United States
Why it was recalled
The reason the FDA lists: “Software issue that can cause an increase in spontaneous software closures.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the states of MA & NC.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99268, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
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About this recall
Is Foundation Medicine Hamilton Microlab STAR Liquid Handler recalled?
Yes. Foundation Medicine, Inc. recalled it on June 10, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Software issue that can cause an increase in spontaneous software closures.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.