Data / Medical devices / United States / Caris MPI, Inc
Caris MPI, Inc: FDA-registered device maker in Phoenix, AZ, United States, 1 PMA approval
Caris MPI, Inc is registered with the FDA (registration 3017020141) in Phoenix, AZ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated November 5, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017020141
- FEI number
- 3008335090
- Address
- 4610 S 44th Pl, Phoenix, AZ, United States, 85040
- Owner or operator
- Caris MPI, Inc (10092014)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 25, 2024
- Registered through
- 2026
- Brand names listed
- MI Cancer Seek
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 5, 2024 | P240010 | MI Cancer Seek | PQP | 8 | October 16, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 17, 2025 | 97258 | Class II | Ongoing | MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with | Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation | accessdata.fda.gov |
Compare with other makers
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.