Oncomine™ Dx Target DNA Control Kit A32442Recalls & reported problems
Life Technologies Corporation · ONC DX TARGET DNA CONTROL · Class 3
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- Mar 16, 2020Class IITerminated
Extended Expiration Date prior to clearance
Z-1704-2020 · Root cause: Incorrect or no expiration date · 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-1706-2020 · Mar 16, 2020 · TerminatedOncomine 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-1707-2020 · Mar 16, 2020 · TerminatedIon 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-1705-2020 · Mar 16, 2020 · TerminatedOncomine 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-1480-2018 · Feb 8, 2018 · TerminatedOncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
- Z-1279-2018 · Dec 4, 2017 · TerminatedOncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in
Other Next generation sequencing oncology panel, somatic or germline variant detection system devices
- Oncomine™ Dx Target Test A32441Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall1 report
- Oncomine™ Dx Target Test User Guides and Assay Definition File A32461Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- Oncomine™ Dx Target RNA Control Kit A32443Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- Oncomine™ Dx Target Test A32441Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- MI Cancer Seek® MCS000Caris Mpi, Inc. · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System1 recall0 reports
- Ion Torrent™ Dx No Template Control Kit A32444Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- Oncomine™ Dx Express Test A50871Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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