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FDAFDA · Food and drugs·Recall number Z-2951-2026

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

Published August 26, 2026 · Recall initiated: June 10, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Software issue that can cause an increase in spontaneous software closures.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Foundation Medicine, Inc.
Distributor
US Nationwide distribution in the states of MA & NC.
Lot
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.
Risk classification
Class II
Area (FDA)
device
Country
United States

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