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MEDICAL DEVICE RECALLMODERATE

Hamilton Microlab STAR PCT Software

Foundation Medicine recalls Hamilton Microlab STAR PCT v2.0.0 over spontaneous software closures.

What to do

Check whether your system uses Protocol Configuration Tool (PCT) v2.0.0 and contact Foundation Medicine for instructions on updating or correcting the software.

Recalled
Listed
Updated
Recall No.
Z-2951-2026
Agency
FDA
Firm
Foundation Medicine, Inc.
Recall ID
99268
Status
ONGOING

Recall at a glance

Quantity recalled
32 units

Why it was recalled

Foundation Medicine is recalling the Hamilton Microlab STAR Liquid Handler Protocol Configuration Tool (PCT) v2.0.0, used to conduct F1CDx and F1LCDx tests, due to a software issue that can cause an increase in spontaneous software closures.

Is mine affected?

This recall covers the product below. If you have it, yours is affected.

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

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Software Defect recalls

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All recalls from Foundation Medicine, Inc.

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Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification