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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 reportsee related information
Date Initiated by FirmAugust 08, 2019
Create DateNovember 22, 2019
Recall Status1 Terminated 3 on July 19, 2021
Recall NumberZ-0535-2020
Recall Event ID 83729
PMA NumberP170019 
Product Classification Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
ProductFoundationOne 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
FEI Number 3010679023
Recalling Firm/
Manufacturer		 Foundation Medicine, Inc.
150 2nd St
Cambridge MA 02141-2115
For Additional Information ContactNicole Green
617-418-2200
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
ActionFirm 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 Commerce8 reports
DistributionMA, NC,IN, OH, GA
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = PQP
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