MI Cancer Seek® MCS000Recalls & reported problems
Caris Mpi, Inc. · MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI) tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed as companion diagnostic indications are not prescriptive or conclusive for labeled use of any specific therapeutic product. · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Jun 17, 2025Class IIOpen, Classified
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Z-2521-2025 · Root cause: Software design · Recall details · FDA record ↗
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 RNA Control Kit A32443Life Technologies Corporation · Next generation sequencing oncology panel, somatic or germline variant detection system1 recall0 reports
- Oncomine™ Dx Target DNA Control Kit A32442Life 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
- 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 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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