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 Firm||October 31, 2018|
|Create Date||December 20, 2018|
|Recall Status1||Open3, Classified|
|Recall Event ID||81614|
|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|
|Foundation Medicine, Inc.|
150 2nd St
Cambridge MA 02141-2115
|For Additional Information Contact||Nicole Green|
617-418-2200 Ext. 7337
|An incorrect test result for a single analyte may have been reported for up to 800 physician reports|
|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|