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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation One Companion Diagnostic (F1CDx

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 Class 2 Device Recall Foundation One Companion Diagnostic (F1CDxsee related information
Date Initiated by FirmJune 18, 2024
Date PostedMay 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1890-2025
Recall Event ID 96802
PMA NumberP170019 
Product Classification Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
ProductFoundationOne Companion Diagnostic (F1CDx)
Code Information Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.
FEI Number 3010679023
Recalling Firm/
Manufacturer		 Foundation Medicine, Inc.
150 2nd St
Cambridge MA 02141-2115
For Additional Information ContactClient Services
888-988-3639
Manufacturer Reason
for Recall		Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
FDA Determined
Cause 2		Software design
ActionOn June 18, 2024, amended reports were sent to customers. It was to alert customers to an amended report that was recently released on 6/18/24. The new report replaces the report of 2/11/24. Additional contact was made on June 20, 2024 to communicate the error and provide the updated report to the customer.
Quantity in Commerce2 units
DistributionUS Nationwide distribution in the state of MI.
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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