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.   

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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=169070

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

Date Initiated by Firm	October 31, 2018
Create Date	December 20, 2018
Recall Status1	Open3, Classified
Recall Number	Z-0649-2019
Recall Event ID	81614
PMA Number	P170019
Product Classification	Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
Product	FoundationOne CDx, Model TG-HS4000 Seq Kit Test

Recalling Firm/ Manufacturer	Foundation Medicine, Inc. 150 2nd St Cambridge MA 02141-2115
For Additional Information Contact	Nicole 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	Other
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.
Quantity in Commerce	800 reports
Distribution	US nationwide