Z-1747-2025Class II

FoundationOne Companion Diagnostic (F1CDx)

Name: Z-1747-2025 FoundationOne Companion Diagnostic (F1CDx)
Creator: Foundation Medicine, Inc.
Published: 2025-04-09
License: https://open.fda.gov/license/

Foundation Medicine, Inc. / initiated 2025-04-09 / Open, Classified

FDA source

Foundation Medicine, Inc. began a recall of FoundationOne Companion Diagnostic (F1CDx) on 2025-04-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1747-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-09
Posted: 2025-05-12
Recalling firm: Foundation Medicine, Inc.
Product: FoundationOne Companion Diagnostic (F1CDx)
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
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.
FDA 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 in commerce: 4 units
Distribution: Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
Product codes and lots: ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1747-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1747-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-12

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)