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Hamilton AutoLys STAR Protocol Configuration Tool Software
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MEDICAL DEVICE RECALLMODERATE

Hamilton AutoLys STAR Protocol Configuration Tool Software

Foundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR due to risk of spontaneous software closures during protocol execution.

What to do

If you operate Hamilton AutoLys STAR equipment with PCT software v1.3.0 at the affected Research Triangle Park laboratory, contact Foundation Medicine immediately for a software update or patch to prevent spontaneous HxRunControl closures during protocol execution.

Recalled
Listed
Updated
Recall No.
Z-1937-2026
Agency
FDA
Firm
Foundation Medicine, Inc.
Recall ID
98640
Status
ONGOING

Recall at a glance

Quantity recalled
10 units

Why it was recalled

Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR laboratory equipment (Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995) used in FoundationOneCDx testing at Research Triangle Park due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.

Is mine affected?

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

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

Where it was sold

Distributed in Massachusetts and North Carolina.

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 →

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification