Z-2951-2026Class II

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

Name: Z-2951-2026 Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and...
Creator: Foundation Medicine, Inc.
Published: 2026-06-10
License: https://open.fda.gov/license/

Foundation Medicine, Inc. / initiated 2026-06-10 / Open, Classified / root cause: software

FDA source

Foundation Medicine, Inc. began a recall of Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx on 2026-06-10. FDA classified it as Class II and gives the reason as "Software issue that can cause an increase in spontaneous software closures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2951-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-10
Posted: 2026-08-14
Recalling firm: Foundation Medicine, Inc.
Product: Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: Software issue that can cause an increase in spontaneous software closures.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 6/10/26 was emailed to consignees. Consignees were instructed to review the impacted equipment list and verify that the PCT V2.0.1 software version has been installed. If software hasn't been updated FMI will follow up to assist with installation. The recall notice is to be forwarded to anyone in the facility or outside the organization that needs to be informed. The notification is to be retained with laboratory records. Questions can be directed to Foundation Medicine at 888-988-3639 or [email protected].
Quantity in commerce: 32 units
Distribution: US Nationwide distribution in the states of MA & NC.
Product codes and lots: Software Version: Protocol 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2951-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2951-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)