FDA Medical Device Recalls (openFDA)
Foundation Medicine, Inc.: FoundationOne Companion Diagnostic (F1CDx)
- Recall number
- Z-1747-2025
- Recalling firm
- Foundation Medicine, Inc.
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Status
- Open, Classified
- Initiated
- 2025-04-09
- Posted
- 2025-05-12
- Terminated
- not on file
- 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 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.
- Quantity
- 4 units
- Distribution
- Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
- Lot, serial or model codes
- ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
- 510(k) numbers
- not on file
- PMA numbers
- ["P170019"]
- Product code
- PQP
- Firm FEI
- 3010679023
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28