Hamilton Microlab STAR Liquid Handler Recall Issued

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Foundation Medicine, Inc. is recalling 32 units of the Hamilton Microlab STAR Liquid Handler due to a software issue causing spontaneous closures.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Software issue that can cause an increase in spontaneous software closures.", distributed us nationwide distribution in the states of ma & nc.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.

Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, devices.

What Happened

Foundation Medicine, Inc. initiated a voluntary recall of the Hamilton Microlab STAR Liquid Handler due to a software issue that can cause an increase in spontaneous software closures.

Which Products Are Affected

The recall affects the Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0, used to conduct F1CDx and F1LCDx. A total of 32 units are involved under recall number Z-2951-2026. Affected equipment IDs include: 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 was to US Nationwide in the states of MA and NC.

What You Should Do

Consumers with questions should contact the recalling firm Foundation Medicine, Inc. at their Cambridge, MA location.

Why This Matters

This Class II recall involves a medical device used in diagnostic testing, where software instability could affect operations.

Source

FDA recall number Z-2951-2026; report date 20260826.

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

What People Ask

What people usually ask about a notice like this one.

What is this FDA recall about?
Foundation Medicine, Inc. is recalling 32 units of the Hamilton Microlab STAR Liquid Handler due to a software issue causing spontaneous closures.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "Software issue that can cause an increase in spontaneous software closures." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.