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Terminated

FoundationOne CDx Test Results

FDA Recall Z-0649-2019 · Posted 2018-12-20

Recalling FirmFoundation Medicine, Inc.
Recall StatusTerminated
Product CodePQP
Date Initiated2018-10-31
Date Terminated2020-04-17
Product Quantity800 reports

Reason for Recall

An incorrect test result for a single analyte may have been reported for up to 800 physician reports

Firm Action

On October 31, 2108, an outreach program was implemented by Foundation Medicine's Medical Affairs team to advise ordering physicians who received reports of possibility that the relevant reports could contain an incorrect test result.

Root Cause

Other

Distribution Pattern

US nationwide

Official Source

View FDA Recall →

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

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