CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Protocol Configuration Tool (PCT) recalled by Foundation Medicine
Foundation Medicine is recalling Protocol Configuration Tool (PCT), distributed in Massachusetts, North Carolina. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1937-2026
- FDA event ID
- 98640
- Recalling firm
- Foundation Medicine, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2026
- FDA classified
- 23 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 24 Mar 2026 | Recall initiated by company | |
| 23 Apr 2026 | Classified by FDA | +30 days |
| 29 Apr 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 distributed
US distribution to North Carolina and Massachusetts.
Questions about this recall
Why was it recalled?
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Which lots are affected?
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
Where was it sold?
US distribution to North Carolina and Massachusetts.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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