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U.S. Department of Health and Human Services

Class 2 Device Recall Hamilton Microlab STAR Liquid Handler

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 Class 2 Device Recall Hamilton Microlab STAR Liquid Handlersee related information
Date Initiated by FirmJune 10, 2026
Date PostedAugust 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2951-2026
Recall Event ID 99268
PMA NumberP200006 P170019 
Product Classification Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
ProductHamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Code Information 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.
FEI Number 3010679023
Recalling Firm/
Manufacturer		 Foundation Medicine, Inc.
150 2nd St
Cambridge MA 02141-2115
For Additional Information ContactClarke Madigan
617-418-2200
Manufacturer Reason
for Recall		Software issue that can cause an increase in spontaneous software closures.
FDA Determined
Cause 2		Software design
ActionAn 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 in Commerce32 units
DistributionUS Nationwide distribution in the states of MA & NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = PQP
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