Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Software design
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
FoundationOne Companion Diagnostic (F1CDx)
Lot / code information
Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.
What the firm is doing
On 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.
DistributionShow detailsHide
US Nationwide distribution in the state of MI.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1890-2025
- FDA device classification · PQPOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Foundation Medicine, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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