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Terminated

FoundationOne CDx test report

FDA Recall Z-0535-2020 · Posted None

Recalling FirmFoundation Medicine, Inc.
Recall StatusTerminated
Product CodePQP
Date Initiated2019-08-08
Date Terminated2021-07-19
Product Quantity8 reports

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

MA, NC,IN, OH, GA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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