Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Software design
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.
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 Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.
What the firm is doing
On 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.
DistributionShow detailsHide
US Nationwide distribution in the state of WI.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1891-2025
- 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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