Z-0578-2026Class II

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

Name: Z-0578-2026 FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Creator: Foundation Medicine, Inc.
Published: 2022-11-08
License: https://open.fda.gov/license/

Foundation Medicine, Inc. / initiated 2022-11-08 / Open, Classified

FDA source

Foundation Medicine, Inc. began a recall of FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 on 2022-11-08. FDA classified it as Class II and gives the reason as "Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0578-2026
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-08
Posted: 2025-11-21
Recalling firm: Foundation Medicine, Inc.
Product: FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
FDA root cause: Under Investigation by firm
Action: On 08 November 2022, Notification Emails with amended reports were emailed to customers. The Foundation Medicine's Medical Affairs team email alerted its customer to a recently issued amended report [Date of Amended Report] for one of your patients [Patient Order Number]. This Amended Report has been issued to update the report template to include the correct [FoundationOneLiquid CDx/FoundationOneCDx] reporting template, including the associated Claims page. Please note that other aspects of this report may have changed from the previous version to reflect the most up-to-date reporting information. If you have questions about this information, please do not hesitate to call 1-888-988-3639 or email: [email protected]. Please confirm receipt of this email or Foundation Medicine can also follow-up with a phone call.
Quantity in commerce: 18 units (17 US, 1 OUS)
Distribution: US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.
Product codes and lots: F1LCDx - TECH-0009 version 6.0; Test Numbers: ORD-XXX6703-01 (JP), ORD-XXXX411-01 (US), ORD-XXXX128-01 (US), ORD-XXXX061-01 (US), ORD-XXXX270-01 (US), ORD-XXXXX94-01 (US), ORD-XXXX058-01 (US), ORD-XXXX099-01 (US), ORD-XXXX089-01 (US), ORD-XXXX252-01 (US), ORD-XXXX640-01 (US), ORD-XXX5300-01 (US), ORD-XXXX453-01 (US), ORD-XXXX101-01 (US), ORD-XXXX070-01 (US), ORD-XXXX231-01 (US), ORD-XXXX496-01 (US), ORD-XXXX202-01 (US).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0578-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0577-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-21
Z-0578-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-21

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)