Home › Device types › PQP
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA product code PQP · Class 3 · Unknown
23
Registered devices
14
Adverse events
18
Recalls
0
510(k) clearances
Devices with this code
oncoReveal CDx — Pillar Biosciences, Inc.oncoReveal CDx Box 3 — Pillar Biosciences, Inc.Ion Torrent — LIFE TECHNOLOGIES CORPORATIONTruSight™ Oncology Comprehensive — ILLUMINA, INC.oncoReveal CDx Box 2 — Pillar Biosciences, Inc.Ion Torrent — LIFE TECHNOLOGIES CORPORATIONOncomine™ Dx Target RNA Control Diluent — LIFE TECHNOLOGIES CORPORATIONOncomine™ Dx Target Test — LIFE TECHNOLOGIES CORPORATIONOncomine™ DX Target DNA Control v2.0 — LIFE TECHNOLOGIES CORPORATIONPiVAT Software — Pillar Biosciences, Inc.Oncomine™ Dx Target Test User Guides and Assay Definition File — LIFE TECHNOLOGIES CORPORATIONOncomine™ Dx Target Test User Guides and Assay Definition File — LIFE TECHNOLOGIES CORPORATIONoncoReveal CDx — Pillar Biosciences, Inc.oncoReveal CDx — Pillar Biosciences, Inc.Oncomine™ Dx Target RNA Control Kit — LIFE TECHNOLOGIES CORPORATIONMI Cancer Seek® — CARIS MPI, INC.Praxis Extended RAS Panel — ILLUMINA, INC.Oncomine™ Dx Target Test — LIFE TECHNOLOGIES CORPORATIONResolution ctDx FIRST Sample Collection Kit — Resolution Bioscience, Inc.Ion Torrent™ Dx No Template Control Kit — LIFE TECHNOLOGIES CORPORATIONOncomine™ Dx Target DNA Control Kit — LIFE TECHNOLOGIES CORPORATIONIon Torrent — LIFE TECHNOLOGIES CORPORATIONOncomine™ Dx Target Test User Guide and Assay Definition File — LIFE TECHNOLOGIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-10 | Foundation Medicine, Inc. | Software issue that can cause an increase in spontaneous software closures. |
| 2026-03-24 | Foundation Medicine, Inc. | Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hami |
| 2026-03-20 | Foundation Medicine, Inc. | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants |
| 2025-06-17 | CARIS LIFE SCIENCES | Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation |
| 2025-04-09 | Foundation 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 |
| 2024-06-18 | Foundation 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 |
| 2023-02-17 | AGILENT TECHNOLOGIES INC./US | Distributed sample collection kit with an unapproved instruction for use. |
| 2023-02-15 | Foundation 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- |
| 2022-11-08 | Foundation 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 |
| 2022-11-08 | Foundation 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 |
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