Class 2 Device Recall FoundationOne CDx

• Date Initiated by Firm: October 31, 2018
• Date Posted: December 20, 2018
• Recall Status: Terminated on April 17, 2020
• 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 Test Results
• Code Information: Specimen Numbers - QRF038638 QRF039891 QRF041785 QRF045568 QRF045791 QRF046784 QRF046978 QRF047089 QRF048328 QRF048779 QRF049054 QRF049231 QRF049653 QRF049780 QRF049795 QRF050115 QRF050274 QRF050299 QRF050506 QRF051201 QRF051302 QRF051412 QRF051560 QRF051610 QRF051635 QRF051756 QRF051768 QRF051787 QRF051832 QRF051882 QRF051892 QRF051920 QRF051925 QRF051943 QRF051952 QRF051954 QRF051968 QRF051975 QRF051979 QRF051982 QRF051987 QRF052308 QRF052311 QRF052315 QRF052324 QRF052327 QRF052356 QRF052356 QRF052363 QRF052364 QRF052387 QRF052391 QRF052392 QRF052395 QRF052423 QRF052425 QRF052438 QRF052448 QRF052467 QRF052486 QRF052507 QRF052509 QRF052509 QRF052518 QRF052521 QRF052539 QRF052580 QRF052581 QRF052587 QRF052886 QRF052905 QRF053180 QRF053280 QRF053574 QRF053624 QRF053630 QRF053637 QRF053651 QRF053808 QRF054060 QRF054282 QRF054282 QRF054297 QRF054300 QRF054309 QRF054335 QRF054358 QRF054390 QRF054393 QRF054400 QRF054439 QRF054446 QRF054446 QRF054478 QRF054490 QRF054500 QRF054501 QRF054533 QRF054540 QRF054549 QRF054565 QRF054570 QRF054571 QRF054600 QRF054602 QRF054611 QRF054615 QRF054617 QRF054620 QRF054621 QRF054622 QRF054623 QRF054628 QRF054631 QRF054633 QRF054636 QRF054640 QRF054642 QRF054645 QRF054646 QRF054648 QRF054649 QRF054651 QRF054653 QRF054657 QRF054659 QRF054660 QRF054664 QRF054665 QRF054666 QRF054687 QRF054689 QRF054690 QRF054691 QRF054694 QRF054695 QRF054697 QRF054698 QRF054700 QRF054701 QRF054702 QRF054703 QRF054704 QRF054705 QRF054706 QRF054708 QRF054710 QRF054712 QRF054714 QRF054715 QRF054716 QRF054717 QRF054719 QRF054721 QRF054724 QRF054725 QRF054728 QRF054729 QRF054732 QRF054733 QRF054734 QRF054736 QRF054737 QRF054738 QRF054739 QRF054740 QRF054742 QRF054743 QRF054746 QRF054748 QRF054750 QRF054751 QRF054752 QRF054753 QRF054754 QRF054755 QRF054756 QRF054756 QRF054757 QRF054759 QRF054760 QRF054760 QRF054762 QRF054763 QRF054764 QRF054765 QRF054766 QRF054768 QRF054770 QRF054771 QRF054775 QRF054776 QRF054779 QRF054780 QRF054781 QRF054782 QRF054783 QRF054784 QRF054786 QRF054787 QRF054790 QRF054791 QRF054792 QRF054793 QRF054797 QRF054799 QRF054800 QRF054801 QRF054804 QRF054805 QRF054807 QRF054808 QRF054811 QRF054812 QRF054814 QRF054815 QRF054816 QRF054817 QRF054819 QRF054821 QRF054822 QRF054824 QRF054825 QRF054829 QRF054829 QRF054832 QRF054835 QRF054844 QRF054845 QRF054848 QRF054850 QRF054851 QRF054853 QRF054854 QRF054855 QRF054855 QRF054858 QRF054859 QRF054860 QRF054862 QRF054864 QRF054865 QRF054866 QRF054867 QRF054871 QRF054872 QRF054875 QRF054876 QRF054877 QRF054881 QRF054882 QRF054883 QRF054884 QRF054885 QRF054887 QRF054888 QRF054888 QRF054889 QRF054890 QRF054892 QRF054896 QRF054897 QRF054898 QRF054900 QRF054903 QRF054904 QRF054905 QRF054908 QRF054910 QRF054911 QRF054912 QRF054914 QRF054916 QRF054917 QRF054918 QRF054920 QRF054923 QRF054924 QRF054925 QRF054926 QRF054927 QRF054930 QRF054931 QRF054932 QRF054934 QRF054938 QRF054939 QRF054940 QRF054942 QRF054943 QRF054944 QRF054945 QRF054946 QRF054947 QRF054948 QRF054949 QRF054950 QRF054952 QRF054954 QRF054955 QRF054956 QRF054958 QRF054959 QRF054960 QRF054964 QRF054967 QRF054971 QRF054972 QRF054977 QRF054979 QRF054984 QRF054985 QRF054990 QRF054991 QRF054993 QRF054993 QRF054996 QRF054999 QRF054999 QRF055000 QRF055001 QRF055002 QRF055006 QRF055009 QRF055010 QRF055011 QRF055013 QRF055014 QRF055015 QRF055015 QRF055018 QRF055019 QRF055020 QRF055021 QRF055026 QRF055026 QRF055027 QRF055028 QRF055032 QRF055040 QRF055041 QRF055042 QRF055043 QRF055045 QRF055047 QRF055052 QRF055054 QRF055055 QRF055056 QRF055060 QRF055061 QRF055063 QRF055064 QRF055065 QRF055066 QRF055067 QRF055071 QRF055072 QRF055074 QRF055075 QRF055080 QRF055081 QRF055082 QRF055083 QRF055084 QRF055085 QRF055087 QRF055093 QRF055113 QRF055119 QRF055120 QRF055121 QRF055122 QRF055123 QRF055124 QRF055125 QRF055126 QRF055127 QRF055128 QRF055131 QRF055137 QRF055137 QRF055138 QRF055139 QRF055140 QRF055141 QRF055142 QRF055143 QRF055148 QRF055149 QRF055150 QRF055152 QRF055153 QRF055154 QRF055155 QRF055157 QRF055158 QRF055159 QRF055162 QRF055165 QRF055166 QRF055168 QRF055170 QRF055171 QRF055172 QRF055173 QRF055174 QRF055175 QRF055176 QRF055177 QRF055178 QRF055182 QRF055183 QRF055185 QRF055186 QRF055187 QRF055189 QRF055190 QRF055194 QRF055196 QRF055197 QRF055198 QRF055200 QRF055201 QRF055202 QRF055203 QRF055204 QRF055206 QRF055207 QRF055209 QRF055210 QRF055211 QRF055213 QRF055215 QRF055216 QRF055217 QRF055219 QRF055221 QRF055223 QRF055225 QRF055226 QRF055228 QRF055231 QRF055232 QRF055233 QRF055234 QRF055235 QRF055237 QRF055239 QRF055240 QRF055241 QRF055243 QRF055243 QRF055245 QRF055247 QRF055248 QRF055249 QRF055250 QRF055251 QRF055252 QRF055253 QRF055254 QRF055255 QRF055256 QRF055257 QRF055258 QRF055259 QRF055261 QRF055263 QRF055265 QRF055267 QRF055268 QRF055270 QRF055270 QRF055271 QRF055272 QRF055273 QRF055274 QRF055275 QRF055277 QRF055279 QRF055280 QRF055281 QRF055282 QRF055283 QRF055284 QRF055285 QRF055286 QRF055286 QRF055287 QRF055289 QRF055290 QRF055291 QRF055293 QRF055294 QRF055295 QRF055299 QRF055300 QRF055302 QRF055303 QRF055304 QRF055306 QRF055306 QRF055308 QRF055309 QRF055310 QRF055312 QRF055313 QRF055314 QRF055315 QRF055316 QRF055316 QRF055317 QRF055318 QRF055319 QRF055320 QRF055321 QRF055324 QRF055327 QRF055329 QRF055330 QRF055333 QRF055334 QRF055335 QRF055336 QRF055337 QRF055342 QRF055344 QRF055345 QRF055347 QRF055348 QRF055349 QRF055351 QRF055352 QRF055353 QRF055354 QRF055355 QRF055357 QRF055358 QRF055360 QRF055361 QRF055362 QRF055363 QRF055367 QRF055368 QRF055369 QRF055370 QRF055375 QRF055376 QRF055377 QRF055380 QRF055382 QRF055385 QRF055387 QRF055390 QRF055391 QRF055392 QRF055393 QRF055394 QRF055395 QRF055397 QRF055399 QRF055400 QRF055403 QRF055404 QRF055405 QRF055407 QRF055408 QRF055409 QRF055410 QRF055411 QRF055412 QRF055414 QRF055417 QRF055417 QRF055418 QRF055419 QRF055421 QRF055423 QRF055429 QRF055432 QRF055449 QRF055455 QRF055459 QRF055463 QRF055464 QRF055465 QRF055467 QRF055468 QRF055470 QRF055471 QRF055472 QRF055473 QRF055476 QRF055477 QRF055477 QRF055479 QRF055480 QRF055482 QRF055483 QRF055484 QRF055490 QRF055491 QRF055492 QRF055494 QRF055496 QRF055498 QRF055499 QRF055500 QRF055502 QRF055509 QRF055513 QRF055514 QRF055515 QRF055516 QRF055517 QRF055517 QRF055518 QRF055519 QRF055520 QRF055521 QRF055522 QRF055524 QRF055526 QRF055527 QRF055529 QRF055530 QRF055531 QRF055533 QRF055535 QRF055537 QRF055538 QRF055539 QRF055540 QRF055541 QRF055542 QRF055546 QRF055550 QRF055551 QRF055555 QRF055557 QRF055561 QRF055561 QRF055563 QRF055565 QRF055571 QRF055572 QRF055573 QRF055574 QRF055576 QRF055577 QRF055577 QRF055579 QRF055581 QRF055584 QRF055585 QRF055586 QRF055588 QRF055591 QRF055593 QRF055595 QRF055596 QRF055596 QRF055598 QRF055600 QRF055601 QRF055605 QRF055610 QRF055611 QRF055623 QRF055625 QRF055625 QRF055628 QRF055631 QRF055633 QRF055640 QRF055642 QRF055643 QRF055644 QRF055648 QRF055650 QRF055651 QRF055655 QRF055657 QRF055658 QRF055660 QRF055664 QRF055667 QRF055668 QRF055668 QRF055669 QRF055671 QRF055675 QRF055676 QRF055679 QRF055683 QRF055684 QRF055686 QRF055687 QRF055690 QRF055691 QRF055694 QRF055696 QRF055698 QRF055699 QRF055708 QRF055710 QRF055711 QRF055712 QRF055714 QRF055717 QRF055720 QRF055724 QRF055725 QRF055727 QRF055731 QRF055735 QRF055739 QRF055742 QRF055742 QRF055744 QRF055748 QRF055753 QRF055754 QRF055754 QRF055755 QRF055756 QRF055759 QRF055760 QRF055761 QRF055765 QRF055767 QRF055770 QRF055771 QRF055772 QRF055773 QRF055774 QRF055775 QRF055777 QRF055778 QRF055779 QRF055780 QRF055781 QRF055784 QRF055786 QRF055788 QRF055789 QRF055790 QRF055794 QRF055795 QRF055796 QRF055805 QRF055806 QRF055809 QRF055810 QRF055813 QRF055815 QRF055816 QRF055817 QRF055819 QRF055820 QRF055827 QRF055829 QRF055833 QRF055834 QRF055836 QRF055837 QRF055840 QRF055841 QRF055845 QRF055846 QRF055847 QRF055852 QRF055859 QRF055862 QRF055865 QRF055872 QRF055874 QRF055908 QRF055983 QRF055996 QRF056013 QRF056019 QRF056029 QRF056029 QRF056031 QRF056035 QRF056051 QRF056057 QRF056063 QRF056084 QRF056095 QRF056100 QRF056104 QRF056117 QRF056118 QRF056143 QRF056143 QRF056144 QRF056152 QRF056175 QRF056180 QRF056207 QRF056210 QRF056219 QRF056231 QRF056239 QRF056255 QRF056256 QRF056258 QRF056261 QRF056266 QRF056275 QRF056279 QRF056310 QRF056310 QRF056326 QRF056334 QRF056339 QRF056356 QRF056379 QRF056382 QRF056440 QRF056510 QRF056523 QRF056534 QRF056535 QRF056549 QRF056553 QRF056556 QRF056565 QRF056620
• 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: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = PQP and Original Applicant = Foundation Medicine, Inc.