Foundation Medicine, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0535-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

FoundationOne CDx test report

Product Classification:

Class II

Date Initiated: August 8, 2019

Date Posted: December 4, 2019

Recall Number: Z-0535-2020

Event ID: 83729

Reason for Recall:

Identified potential false positive MSI-H on the test reports provided to the physicians.

Status: Terminated

Product Quantity: 8 reports

Code Information:

Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01

Distribution Pattern:

MA, NC,IN, OH, GA

Voluntary or Mandated:

Voluntary: Firm initiated