Oncomine™ Dx Target Test User Guides and Assay Definition File A32461Recalls & reported problems

Life Technologies Corporation · ODXTT UG AND ADF 1.8 - US · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (P160045); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Dec 4, 2017Class IITerminated
The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.
Z-1279-2018 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160045. One submission often covers many models, so check the product and lot details in each record.

Z-1704-2020 · Mar 16, 2020 · Terminated
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.
Z-1705-2020 · Mar 16, 2020 · Terminated
Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
Z-1707-2020 · Mar 16, 2020 · Terminated
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
Z-1706-2020 · Mar 16, 2020 · Terminated
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
Z-1480-2018 · Feb 8, 2018 · Terminated
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

Device details

UDI-DI	`10190302006071`
Brand	Oncomine™ Dx Target Test User Guides and Assay Definition File
Model	A32461
Company	Life Technologies Corporation
Product code	PQP · Next generation sequencing oncology panel, somatic or germline variant detection system
Class	Class 3
FDA submission	P160045
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 4, 2024

Device type (GMDN): Human genomic analysis interpretive software

An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile. This software is not an IVD device.

Other Next generation sequencing oncology panel, somatic or germline variant detection system devices

Oncomine™ Dx Target Test A32441
Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system
1 recall1 report
Oncomine™ Dx Target RNA Control Kit A32443
Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system
1 recall0 reports
Oncomine™ Dx Target DNA Control Kit A32442
Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system
1 recall0 reports
Oncomine™ Dx Target Test A32441
Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system
1 recall0 reports
Ion Torrent™ Dx No Template Control Kit A32444
Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system
1 recall0 reports
MI Cancer Seek® MCS000
Caris Mpi, Inc. · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
1 recall0 reports
Oncomine™ Dx Express Test A50871
Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system
1 report

All Next generation sequencing oncology panel, somatic or germline variant detection system devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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