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U.S. Department of Health and Human Services

Class 2 Device Recall FoundationOneCDx (F1CDx)

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 Class 2 Device Recall FoundationOneCDx (F1CDx)see related information
Date Initiated by FirmFebruary 15, 2023
Date PostedMay 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1891-2025
Recall Event ID 96804
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 Number: ORD-XXXXX04-01; 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		An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
FDA Determined
Cause 2		Software design
ActionOn February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the state of WI.
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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