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U.S. Department of Health and Human Services

Class 2 Device Recall Foundationone CDx test report

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  Class 2 Device Recall Foundationone CDx test report see related information
Date Initiated by Firm August 08, 2019
Create Date November 22, 2019
Recall Status1 Terminated 3 on July 19, 2021
Recall Number Z-0535-2020
Recall Event ID 83729
PMA Number P170019 
Product Classification Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
Product FoundationOne CDx test report
Code Information Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
Recalling Firm/
Foundation Medicine, Inc.
150 2nd St
Cambridge MA 02141-2115
For Additional Information Contact Nicole Green
Manufacturer Reason
for Recall
Identified potential false positive MSI-H on the test reports provided to the physicians.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = PQP and Original Applicant = Foundation Medicine, Inc.