FoundationOne Diagnostic (Foundation Medicine) – Variant Reporting (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FoundationOne Companion Diagnostic (F1CDx)
Brand
Foundation Medicine, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
Foundation Medicine, Inc. is recalling FoundationOne Companion Diagnostic (F1CDx) due to Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Recommended Action
Per FDA guidance
On April 9, 2025 URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters were sent to customers. Asked Customer Immediate Actions: Foundation Medicine respectfully requests your support with the following actions: 1. Review, complete, sign and return the attached business reply form to be returned in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 2. Forward this notice to anyone in your facility that needs to be informed. 3. If there is any impact that requires this notice to be forwarded to another facility, contact that facility and provide them with this letter. 4. Keep a copy of this notice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Foundation Medicine apologizes for any inconvenience caused by this issue. If any further information or support concerning this issue is needed, please contact Foundation Medicine at any time.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026