FDA Device recall Z-0649-2019
FoundationOne CDx Test Results
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of FoundationOne CDx Test Results by Foundation Medicine, citing an incorrect test result for a single analyte may have been reported for up to 800 physician reports.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0649-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-31 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Foundation Medicine |
| Distribution | US |
Product
FoundationOne CDx Test Results
Reason
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Identifiers
| code_info | Specimen Numbers - QRF038638 QRF039891 QRF041785 QRF045568 QRF045791 QRF046784 QRF046978 QRF047089 QRF048328…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 QRF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0649-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.