Foundation Medicine, Inc. recalls
6 federal recalls on file, showing the 3 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Foundation Medicine, Inc. and put it in plain English.
Recent recalls
Reign Medical bone fixation staples recalled for inadequate testingReign Medical's Clench Staple System (Compression) was distributed without adequate performance testing and requires additional FDA clearance. The device is used in bone fixation procedures. About 600 units were distributed nationwide.
ModerateFDASep 23, 2026
- Foundation Medicine Hamilton Microlab STAR software recalled for crash risk
Foundation Medicine's Protocol Configuration Tool (PCT) v2.0.0, used with Hamilton Microlab STAR liquid handlers to conduct F1CDx and F1LCDx tests, has a software issue that can cause the application to close unexpectedly. This affects 32 units distributed in Massachusetts and North Carolina.
ModerateFDAAug 26, 2026
- Foundation Medicine FoundationOne CDx tests recalled for missing claims pages
Foundation Medicine sent some test reports to customers without the companion diagnostic (CDx) Claims Page. The missing pages were sent later in amended reports, within 7 days of the issue. This recall covers 2 products, FoundationOne CDx and FoundationOne Liquid CDx, with 77 affected units total.
ModerateFDADec 3, 20252 products