FoundationOne CDx test report — Class II medical device recall Z-0535-2020
Terminated recall by Foundation Medicine, Inc., reported 2019-12-04, distributed in GA, IN, MA, NC, OH. Identified potential false positive MSI-H on the test reports provided to the physicians.
| Recall number | Z-0535-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Foundation Medicine, Inc., Cambridge, MA, United States |
| Recall initiated | 2019-08-08 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-07-19 |
| Distributed | GA, IN, MA, NC, OH |
| Quantity | 8 reports |
| Serial numbers | QRF128938.01, QRF149634.01, QRF149795.01, QRF150009.01, QRF150108.01, QRF150117.01, QRF150228.01, QRF150247.01 |
Product
FoundationOne CDx test report
Reason for recall
Identified potential false positive MSI-H on the test reports provided to the physicians.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0535-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.