0 510(k) clearances · 19 PMAs · 6 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-08-14 | P230011-S006 | TruSight Oncology Comprehensive | Panel Track | PQP | — | — |
| 2026-06-26 | P230011-S002 | TruSight Oncology Comprehensive | Normal 180 Day Track | PQP | — | — |
| 2026-04-23 | P230011-S007 | TruSight Oncology Comprehensive | Real-Time Process | PQP | — | — |
| 2025-09-19 | P230011-S005 | TruSight Oncology Comprehensive | 30-Day Notice | PQP | — | — |
| 2025-09-05 | P230011-S004 | TruSight Oncology Comprehensive | 30-Day Notice | PQP | — | — |
| 2025-04-18 | P230011-S003 | TruSight Oncology Comprehensive | 30-Day Notice | PQP | — | — |
| 2024-11-07 | P230011-S001 | TruSight Oncology Comprehensive | 30-Day Notice | PQP | — | — |
| 2024-08-21 | P230011 | TruSight Oncology Comprehensive | Original | PQP | — | — |
| 2023-02-17 | P160038-S025 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2023-01-13 | P160038-S024 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2022-08-30 | P160038-S023 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2022-07-05 | P160038-S022 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2022-03-28 | P160038-S021 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2021-07-29 | P160038-S019 | Praxis Extended RAS Panel | Normal 180 Day Track No User Fee | PQP | — | — |
| 2021-05-21 | P160038-S020 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2020-12-04 | P160038-S018 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2020-09-02 | P160038-S017 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2020-04-28 | P160038-S016 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| 2020-01-24 | P160038-S015 | Praxis Extended RAS Panel | 30-Day Notice | PQP | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-10-28 | Class II | Ongoing | Z-0884-2026 | Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5… | — | An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets t… |
| 2023-04-05 | Class II | Completed | Z-1977-2023 | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. | — | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| 2023-04-05 | Class II | Completed | Z-1976-2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software | — | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| 2022-05-03 | Class II | Completed | Z-1260-2022 | illumina Model NextSeq 550 Dx REF 20005715 | — | cybersecurity vulnerability |
| 2022-05-03 | Class II | Completed | Z-1259-2022 | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq … | — | cybersecurity vulnerability |
| 2022-02-22 | Class II | Completed | Z-0854-2022 | Illumina NextSeq 550Dx, REF: 20005715, CE, IVD | — | There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an… |
| Date | K-number | Device | Code | Class | Specialty |
|---|