Hilden, DE · 10 510(k) clearances · 30 PMAs · 4 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | Class II | Microbiology | 5 | 2026-03-09 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Class II | Microbiology | 3 | 2025-08-27 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | Class II | Microbiology | 1 | 2026-08-06 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | Class II | Microbiology | 1 | 2024-10-29 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-05-06 | P180043-S010 | QIAGEN therascreen® FGFR RGQ RT-PCR Kit | Real-Time Process | OWD | — | — |
| 2026-01-23 | P010033-S052 | QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test | 30-Day Notice | NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Unknown |
| 2025-11-21 | P010033-S051 | QuantiFERON-TB Gold Plus Test | Real-Time Process | NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Unknown |
| 2025-10-22 | P190001-S002 | therascreen® PIK3CA RGQ PCR Kit | Normal 180 Day Track | OWD | — | — |
| 2025-10-03 | P180043-S007 | QIAGEN therascreen® FGFR RGQ RT-PCR Kit | Normal 180 Day Track | OWD | — | — |
| 2025-01-16 | P110027-S018 | therascreen® KRAS RGQ PCR Kit | Normal 180 Day Track | OWD | — | — |
| 2024-12-06 | P180043-S008 | therascreen FGFR RGQ PCR Kit | Normal 180 Day Track No User Fee | OWD | — | — |
| 2024-10-23 | P180043-S009 | therascreen FGFR RGQ RT-PCR Kit | 30-Day Notice | OWD | — | — |
| 2024-06-21 | P110027-S017 | therascreen® KRAS RGQ PCR Kit | Normal 180 Day Track | OWD | — | — |
| 2024-02-09 | P010033-S050 | QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test | 30-Day Notice | NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Unknown |
| 2023-12-22 | P180043-S006 | therascreen FGFR RGQ RT-PCR Kit | 30-Day Notice | OWD | — | — |
| 2023-12-15 | P010033-S049 | QuantiFERON®-TB Gold Plus Test | 30-Day Notice | NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Unknown |
| 2023-10-06 | P110027-S016 | QIAGEN therascreen® KRAS RGQ PCR Kit | Special (Immediate Track) | OWD | — | — |
| 2023-09-15 | P180043-S005 | therascreen FGFR RGQ RT-PCR Kit | 30-Day Notice | OWD | — | — |
| 2023-06-29 | P210002 | therascreen PDGFRA RGQ PCR Kit | Original | OWD | — | — |
| 2023-06-27 | P190026-S001 | therascreen BRAF V600E RGQ PCR Kit | 30-Day Notice | OWD | — | — |
| 2023-01-24 | P010033-S048 | QUANTIFERON®-TB Gold Plus Test | Real-Time Process | NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Unknown |
| 2022-12-12 | P110027-S013 | therascreen KRAS RGQ PCR Kit | Normal 180 Day Track | OWD | — | — |
| 2022-07-11 | P110027-S015 | therascreen KRAS RGQ PCR Kit | 30-Day Notice | OWD | — | — |
| 2022-06-17 | P110027-S014 | therascreen KRAS RGQ PCR Kit | Special (Immediate Track) | OWD | — | — |
| 2021-12-13 | P010033-S047 | QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus | Normal 180 Day Track | NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Unknown |
| 2021-11-16 | P180043-S003 | therascreen FGFR RGQ RT-PCR Kit | Real-Time Process | OWD | — | — |
| 2021-07-07 | P120022-S022 | therascreen EGFR RGQ PCR Kit | Real-Time Process | OWD | — | — |
| 2021-05-28 | P110027-S012 | therascreen KRAS RGQ PCR KIT | Panel Track | OWD | — | — |
| 2020-08-18 | P180043-S001 | therascreen FGFR RGQ RT-PCR Kit | Normal 180 Day Track | OWD | — | — |
| 2020-04-15 | P190026 | therascreen BRAF V600E RGQ PCR Kit | Original | OWD | — | — |
| 2020-04-03 | P190001-S001 | therascreen PIK3CA RGQ PCR Kit | 30-Day Notice | OWD | — | — |
| 2020-04-03 | P180043-S002 | therascreen FGFR RGQ PCR Kit | 30-Day Notice | OWD | — | — |
| 2020-04-03 | P120022-S021 | therascreen EGFR RGQ PCR Kit | 30-Day Notice | OWD | — | — |
| 2020-04-03 | P110027-S011 | therascreen KRAS RGQ PCR Kit | 30-Day Notice | OWD | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-08-22 | Class II | Ongoing | Z-2665-2023 | therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection o… | — | Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false … |
| 2023-05-19 | Class II | Ongoing | Z-2246-2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intende… | — | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated |
| 2023-05-19 | Class II | Ongoing | Z-2245-2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sample… | — | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated |
| 2023-05-09 | Class II | Ongoing | Z-2215-2023 | QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-C… | — | If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that l… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-06 | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | PAM | Class II | Microbiology |
| 2026-03-09 | K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | Class II | Microbiology |
| 2025-10-22 | K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | Class II | Microbiology |
| 2025-08-27 | K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QOF | Class II | Microbiology |
| 2025-02-28 | K250324 | QIAstat-Dx GI Panel 2 Mini B | PCH | Class II | Microbiology |
| 2025-01-08 | K243813 | QIAstat-Dx GI Panel 2 Mini B&V | PCH | Class II | Microbiology |
| 2024-10-29 | K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | PLO | Class II | Microbiology |
| 2024-10-25 | K242353 | QIAstat-Dx Respiratory Panel Mini | QOF | Class II | Microbiology |
| 2024-05-31 | K220062 | QIAstat-Dx Gastrointestinal Panel 2 | PCH | Class II | Microbiology |
| 2024-05-10 | K233100 | QIAstat-Dx® Respiratory Panel Plus | QOF | Class II | Microbiology |