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Lower risk Medical device recall · FDA · Published June 10, 2026

Foundation Medicine Hamilton Microlab STAR Liquid Handler PCT v2.0.0 Software Recall

Foundation Medicine recalls Hamilton Microlab STAR Liquid Handler Protocol Configuration Tool v2.0.0 due to software issues causing spontaneous closures. Affected units include specific equipment IDs for F1CDx and F1LCDx testing.

🇺🇸 FDA recall #Z-2951-2026Medical deviceFoundation Medicine ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Foundation Medicine is recalling the Hamilton Microlab STAR Liquid Handler's Protocol Configuration Tool (PCT) v2.0.0 software version because it can cause the software to close unexpectedly during use. This could disrupt laboratory testing procedures for specific diagnostic applications. Read more at govinfonow.com/recall/698088-foundation-medicine-hamilton-microlab-star-liquid-handler-pct-v2-0.

Source Summary by GovInfoNow · govinfonow.com/recall/698088-foundation-medicine-hamilton-microlab-star-liquid-handler-pct-v2-0 · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2951-2026

Cite this page

“Foundation Medicine Hamilton Microlab STAR Liquid Handler PCT v2.0.0 Software Recall.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/698088-foundation-medicine-hamilton-microlab-star-liquid-handler-pct-v2-0. Based on FDA recall #Z-2951-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2951-2026%22&limit=1).

Why it’s dangerous

The software issue causes the Protocol Configuration Tool (PCT) v2.0.0 to close unexpectedly during operation. This could lead to interruptions in laboratory testing processes but does not pose a direct physical hazard to users.

Who’s affected

Laboratory users who conduct F1CDx and F1LCDx tests with the Hamilton Microlab STAR Liquid Handler may be affected. Those using the specific equipment IDs listed in the recall are most at risk.

How to tell if you have this one

Check if your Hamilton Microlab STAR Liquid Handler has the Protocol Configuration Tool (PCT) v2.0.0 software version. Affected units include specific equipment IDs listed in the recall notice for F1CDx and F1LCDx testing.

  • Brand
    Foundation Medicine
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update Software

    Contact Foundation Medicine to update to a newer version of the Protocol Configuration Tool (PCT) software.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of MA & NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Massachusetts, North Carolina.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jun 10, 202612. FDA classified it Class II: Aug 14, 202623. Published in FDA’s Enforcement Report: Aug 26, 202634. Added to GovInfoNow: Sep 8, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2951-2026 (June 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2951-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA