Thursday, January 10, 2019

Very Brief Blog: FDA Issues Recall for Some Foundation One CDx Test Reports re TMB

Update:  This blog appeared 7 am on January 10.  

A day later, on January 11, Genomeweb reported that FMI had resolved the issue (here).  The FMI announcement clarified the error described on the FDA website was related to total mutational burden (TMB) reporting.   


FDA issues innumerable notices on device recalls.   FDA current shows an open recall notice on certain FMI FoundationOne CDx test reports.

Date Initiated by FirmOctober 31, 2018
Create DateDecember 20, 2018
Recall Status1Open3, Classified
Recall NumberZ-0649-2019
Recall Event ID81614
PMA NumberP170019 
Product ClassificationNext generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
ProductFoundationOne CDx, Model TG-HS4000 Seq Kit Test  
Recalling Firm/
Foundation Medicine, Inc.
150 2nd St
Cambridge MA 02141-2115
For Additional Information ContactNicole Green
617-418-2200 Ext. 7337
Manufacturer Reason
for Recall
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
FDA Determined
Cause 2
ActionOn 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.
Quantity in Commerce800 reports
DistributionUS nationwide