Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026

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

Foundation Medicine, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Foundation Medicine, Inc. · 150 2nd St · Cambridge, MA · 02141-2115

Is this the product you have?

  • Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Lot codes and dates
  • Software VersionProtocol 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
Amount recalled
32 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 5:51 PM UTC

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