|
Class 2 Device Recall Foundationone CDx test report |
 |
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/ Manufacturer |
Foundation Medicine, Inc. 150 2nd St Cambridge MA 02141-2115
|
For Additional Information Contact |
Nicole 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 |
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.
|
|
|
|