Skip to content

Agendia Inc

US Last updated 25 Oct 2026

Devices
8
Registries
FDA 510(k)FDA
FDA recalls
1

Catalogue8

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2010

    • 3 Mar 2010 Z-1321-2010 Unclassified (pre-2012) Terminated Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting of risk did not cause direct injury to patients. However, if used by physicians as the sole basis for decision-making, affected patients may have received unnecessary therapy.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Agendia NV Amsterdam Noord-Holland · NL FEI 3017845262

Information

Country
US
Address
22 Morgan, Irvine, CA, 92618
FDA FEI number
3007297853