Z-1927-2026Class II

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Name: Z-1927-2026 Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Creator: Foundation Medicine, Inc.
Published: 2026-03-20
License: https://open.fda.gov/license/

Foundation Medicine, Inc. / initiated 2026-03-20 / Open, Classified

FDA source

Foundation Medicine, Inc. began a recall of Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) on 2026-03-20. FDA classified it as Class II and gives the reason as "Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1927-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-20
Posted: 2026-04-22
Recalling firm: Foundation Medicine, Inc.
Product: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
FDA root cause: Under Investigation by firm
Action: Foundation Medicine notified consignees via emailed letter on about 03/20/2026. Consignees were instructed to review, complete, sign and return the provided business reply form and review inventory and identify affected units, quarantine those units, and return to the FMI Boston Warehouse quarantine location via standard laboratory transfer practices. Consignees were also instructed to forward the notification to anyone within the facility that should be informed and if there is any impact that requires this notice to be forwarded to another facility, including facilities where units of inventory may have been transferred, contact that facility and provide them with this letter. Consignees were asked to retain the letter with laboratory records made aware that Foundation Medicine will work with the supplier of these components to replace impacted units.
Quantity in commerce: 163 units
Distribution: US Nationwide distribution in the states of Massachusetts and North Carolina.
Product codes and lots: Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1927-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

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)