Recall Z-2951-2026 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
| Date | Aug 14, 2026 (initiated Jun 10, 2026) |
| Status | Open, Classified |
| Reason | Software issue that can cause an increase in spontaneous software closures. |
| 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 QACTAdverseEventReporting@foundationmedicine.com. |
| Quantity | 32 units |
| Distribution | US Nationwide distribution in the states of MA & NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.