Z-0535-2020Class II

FoundationOne CDx test report

Name: Z-0535-2020 FoundationOne CDx test report
Creator: Foundation Medicine, Inc.
Published: 2019-08-08
License: https://open.fda.gov/license/

Foundation Medicine, Inc. / initiated 2019-08-08 / Terminated

FDA source

Foundation Medicine, Inc. began a recall of FoundationOne CDx test report on 2019-08-08. FDA classified it as Class II and gives the reason as "Identified potential false positive MSI-H on the test reports provided to the physicians". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0535-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-08
Posted: 2019-11-22
Terminated: 2021-07-19
Recalling firm: Foundation Medicine, Inc.
Product: FoundationOne CDx test report
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: Identified potential false positive MSI-H on the test reports provided to the physicians.
FDA root cause: Under Investigation by firm
Action: Firm informed the physicians via phone stating: 1. They had recently received may have an incorrect MSI-H result which could be erroneous due to a possible false positive and to not use the MSI analyte to prescribe treatment. 2. The prescribing physicians were also told that an amended report designating MSI as undetermined would be issued immediately. 3. The physicians were asked if any treatment plan using the MSI result had been started and all confirmed that no treatment plan utilizing the MSI analyte had been used. 4. They were also informed of the availability of FMI Medical Affairs staff physicians to provide additional information or answer any follow questions that they may have.
Quantity in commerce: 8 reports
Distribution: MA, NC,IN, OH, GA
Product codes and lots: Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0535-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0535-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

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)