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Oncomine™ Dx Target Test User Guides and Assay Definition File

LIFE TECHNOLOGIES CORPORATION · Model A32461 · UDI-DI 10190302006071

PQP Prescription
0
510(k) clearances
14
Adverse events
18
Recalls
12
Facilities

Description

ODXTT UG AND ADF 1.8 - US

Recalls

DateFirmReason
2026-06-10Foundation Medicine, Inc.Software issue that can cause an increase in spontaneous software closures.
2026-03-24Foundation Medicine, Inc.Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
2026-03-20Foundation Medicine, Inc.Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
2025-06-17CARIS LIFE SCIENCESDue to an incorrect test results provided that indicated the incorrect drug therapy recommendation
2025-04-09Foundation Medicine, Inc.Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3)
2024-06-18Foundation Medicine, Inc.Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of
2023-02-17AGILENT TECHNOLOGIES INC./USDistributed sample collection kit with an unapproved instruction for use.
2023-02-15Foundation Medicine, Inc.An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report
2022-11-08Foundation Medicine, Inc.Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
2022-11-08Foundation Medicine, Inc.Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.