Medical Device Recall: FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Foundation Medicine, Inc. · November 8, 2022
Reason for Recall
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Distribution
US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.
States Affected
NATIONWIDE
Quantity Affected
59 units (39 US, 20 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0577-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.