Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Foundation Medicine, Inc. · Software issue that can cause an increase in spontaneous software closures.
Open FDA's page for this record- Cfres ID
- 221172
- Product res number
- Z-2951-2026
- Event date initiated
- 2026-06-10
- Event date posted
- 2026-08-14
- Recall status
- Open, Classified
- Res event number
- 99268
- Product code
- PQP
- Product description
- Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- Firm FEI number
- 3010679023
- Recalling firm
- Foundation Medicine, Inc.
- Address 1
- 150 2nd St
- City
- Cambridge
- State
- MA
- Postal code
- 02141-2115
- Additional info contact
- Clarke Madigan 617-418-2200
- Reason for recall
- Software issue that can cause an increase in spontaneous software closures.
- Root cause description
- Software design
- Product quantity
- 32 units
- Distribution pattern
- US Nationwide distribution in the states of MA & NC.
- Code info
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.
- 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.
- PMA numbers
- P200006, P170019
- Harmonized identifiers (openFDA)
- Device name
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Medical specialty description
- Unknown
- Device class
- 3
- PMA number
- P240010, P260004, P160038, P250027, P250036, P170019, P240040, P190032, P200006, P210011, P200016, P200010, P210040, P230011, P190014, P160045, P200011, P160018
- Registration number
- 3017020141, 3013200421, 3003335080, 3010679023, 3010889807, 3031598391, 3012090384, 3030654068, 3011104381, 3003218906, 3020703032, 3007287152
- FEI number
- 3013200421, 3003335080, 3010679023, 3010889807, 3016560486, 3031598391, 3012090384, 3030654068, 3008335090, 3011104381, 3003218906, 3007287152