Recall Z-1747-2025 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
FoundationOne Companion Diagnostic (F1CDx)
| Date | May 12, 2025 (initiated Apr 9, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 facili |
| Quantity | 4 units |
| Distribution | Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.