FoundationOne Companion Diagnostic (F1CDx)
This recall is currently active, issued May 12, 2025. It was issued by Foundation Medicine, Inc..
- Company
- Foundation Medicine, Inc.
- Recall Initiated
- April 9, 2025
- Posted
- May 12, 2025
- Recall Number
- Z-1747-2025
- Quantity
- 4 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
Lot / Code Info
ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
Root Cause
Under Investigation by firm
Action Taken
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.