Qiagen, GmbH
FDA Regulatory Profile
Qiagen, GmbH appears in FDA public data with 6 recalls, 16 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2665-2023, Class II) was initiated on August 22, 2023. Its most recent 510(k) clearance was granted on March 9, 2026.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 16
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2665-2023 | Class II | therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument | August 22, 2023 |
| Z-2245-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharynge | May 19, 2023 |
| Z-2246-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qual | May 19, 2023 |
| Z-2215-2023 | Class II | QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucl | May 9, 2023 |
| Z-2596-2018 | Class II | EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. | May 28, 2018 |
| Z-0274-2018 | Class II | QIAamp DSP Virus Kit Cat. No. 60704 | July 22, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | March 9, 2026 |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | October 22, 2025 |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | August 27, 2025 |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | February 28, 2025 |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | January 8, 2025 |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | October 29, 2024 |
| K242353 | QIAstat-Dx Respiratory Panel Mini | October 25, 2024 |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | May 31, 2024 |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | May 10, 2024 |
| K183597 | QIAstat-Dx Respiratory Panel | May 18, 2019 |
| K172287 | ipsogen JAK2 RGQ PCR Kit | January 12, 2018 |
| DEN160028 | ipsogen JAK2 RGQ PCR Kit | March 27, 2017 |
| K142738 | artus HSV-1/2 QS-RGQ MDx Kit | December 19, 2014 |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | April 4, 2014 |
| K113319 | ROTOR-GENE Q MDX | February 6, 2012 |
| K113323 | ARTUS INFL A/B RG RT-PCR KIT | February 6, 2012 |