Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
FDA device recall Z-2951-2026 · posted 2026-08-14 · Open, Classified
Recall details
- Recalling firm
- Foundation Medicine, Inc.
- Reason for recall
- Software issue that can cause an increase in spontaneous software closures.
- Action taken
- 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 QACTAdverseEventReporting@foundationmedicine.com.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- PQP
- Quantity affected
- 32 units
- Distribution
- US Nationwide distribution in the states of MA & NC.
- Date initiated
- 2026-06-10
- Date posted
- 2026-08-14
- Location
- Cambridge, MA
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