---
title: "Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR u... — FDA record Z-1937-2026 | Is It on Recall"
description: "Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hami"
url: https://isitonrecall.com/recall/fda-device-z-1937-2026-protocol-configuration-tool-pct-software-v1-3-0-for-hamilton-autolys-star-used-within-foundationonec/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) inst... — FDA record Z-1937-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 24, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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.
- **Reason**: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
- **Classification**: Class II
- **Recalling firm**: Foundation Medicine, Inc.
- **Quantity**: 10 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1937-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1937-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US distribution to North Carolina and Massachusetts.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)

## Dates in the source

- **Report date**: Apr 29, 2026
- **Recall initiation date**: Mar 24, 2026
- **Center classification date**: Apr 23, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1937-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Foundation Medicine, Inc. records](https://isitonrecall.com/brand/foundation-medicine-inc/)