Qiagen
Germantown, MD, US
QIAGEN appears in FDA device records in Germantown, MD. FDA records list 26 510(k) clearances between and , 158 PMA records and 2 registered establishments. As of , FDA records show 37 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Qiagen carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Digene Corp.510(k), recall
- Qiagen Gaithersburg, Inc.PMA, enforcement report, recall
- Qiagen Sciences, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 26 510(k) clearances for Qiagen between 1997 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 3 |
| 2012 | 2 |
| 2014 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | PAM | Substantially Equivalent | |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | Substantially Equivalent | |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | Substantially Equivalent | |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QOF | Substantially Equivalent | |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | PCH | Substantially Equivalent | |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | PCH | Substantially Equivalent | |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | PLO | Substantially Equivalent | |
| K242353 | QIAstat-Dx Respiratory Panel Mini | QOF | Substantially Equivalent | |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | PCH | Substantially Equivalent | |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | QOF | Substantially Equivalent | |
| K183597 | QIAstat-Dx Respiratory Panel | OCC | Substantially Equivalent | |
| K172287 | ipsogen JAK2 RGQ PCR Kit | PSU | Substantially Equivalent | |
| DEN160028 | ipsogen JAK2 RGQ PCR Kit | PSU | Unknown | |
| K142738 | artus HSV-1/2 QS-RGQ MDx Kit | OQO | Substantially Equivalent | |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | OZN | Substantially Equivalent | |
| K113323 | ARTUS INFL A/B RG RT-PCR KIT | OCC | Substantially Equivalent | |
| K113319 | ROTOR-GENE Q MDX | OOI | Substantially Equivalent | |
| K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | LSK | Substantially Equivalent | |
| K010893 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 | LSL | Substantially Equivalent | |
| K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 | LSK | Substantially Equivalent | |
| K981567 | HYBRID CAPTURE II CT/GC TEST | LSL | Substantially Equivalent | |
| K981485 | HYBRID CAPTURE II GC-ID | LSL | Substantially Equivalent | |
| K990023 | HYBRID CAPTURE II CT-ID TEST | LSK | Substantially Equivalent | |
| K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | LJO | Substantially Equivalent | |
| K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER | JJQ | Substantially Equivalent | |
| K971586 | DIGENE CERVICAL BRUSH | HHT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1122376 | 3003572099 | QIAGEN | 19300 Germantown Rd, Germantown, MD 20874 US | 2026 | and 2 more, listed in full below |
| 3004013603 | 3004013603 | QIAGEN, GMBH | QIAGEN STRASSE 1, HILDEN North Rhine-Westphalia 40724 DE | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LJOAntigen, Iha, Cytomegalovirus
- KXGApplicator, Absorbent Tipped, Sterile
- OZNC. Difficile Toxin Gene Amplification Assay
- JJHClinical Sample Concentrator
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- PABCytomegalovirus (Cmv) Dna Quantitative Assay
- LSKDna-Reagents, Chlamydia
- LSLDna-Reagents, Neisseria
- PHGDroplet Digital Pcr System
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- PPMGeneral Purpose Reagent
- PAMGram-Positive Bacteria And Their Resistance Markers
- OQOHerpes Simplex Virus Nucleic Acid Amplification Assay
- NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).
- PSUJak2 Gene Mutation Detection Test
- MAQKit, Dna Detection, Human Papillomavirus
- PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- OHQMulti-Analyte Controls Unassayed
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- QBBPlacental Alpha Microglobulin-1 Immunoassay
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- MVUReagents, Specific, Analyte
- OOIReal Time Nucleic Acid Amplification System
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- OWDSomatic Gene Mutation Detection System
- HHTSpatula, Cervical, Cytological
- JQWStation, Pipetting And Diluting, For Clinical Use
- NTWSystem, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
- NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Recall records
Showing 25 of 37| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1504-2025 | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. | Class II | Open, Classified | |
| Z-2353-2024 | QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1 | Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay. | Class II | Open, Classified | |
| Z-1508-2024 | EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230 | Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost | Class II | Open, Classified | |
| Z-2665-2023 | therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD) | 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 negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid | Class II | Open, Classified | |
| 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 intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214 | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated | Class II | Open, Classified | |
| Z-2245-2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223 | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated | Class II | Open, Classified | |
| Z-2215-2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223 | 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 lead to a run abortion will occur and no results will be reported | Class II | Open, Classified | |
| Z-1683-2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 | Faulty cartridges in the lot could result in false test results. | Class II | Open, Classified | |
| Z-1652-2022 | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects | Class II | Open, Classified | |
| Z-1651-2022 | therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects | Class II | Open, Classified | |
| Z-1650-2022 | therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects | Class II | Open, Classified | |
| Z-0952-2022 | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) | False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit. | Class II | Open, Classified | |
| Z-0951-2022 | therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) | False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit. | Class II | Open, Classified | |
| Z-1746-2022 | QIAcube Connect MDx, Model No. 9003070 | During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results. | Class II | Open, Classified | |
| Z-0455-2022 | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 | The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur. | Class II | Terminated | |
| Z-0941-2021 | SARS-CoV-2 Antigen Test | QIAGEN has become aware of the potential for false positive results to occur with some patient samples. | Class II | Terminated | |
| Z-0937-2021 | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121 | Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use. | Class II | Terminated | |
| Z-2938-2020 | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider. | There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis. | Class II | Terminated | |
| Z-2290-2020 | therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 | There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result. | Class II | Terminated | |
| Z-1636-2020 | AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box) | An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute. | Class II | Terminated | |
| Z-1476-2020 | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays. | When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment | Class II | Terminated | |
| Z-2319-2019 | QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument | QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting | Class II | Open, Classified | |
| Z-2088-2019 | Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation | Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) | Class I | Terminated | |
| Z-1891-2019 | RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular biological techniques. It deploys an optimized silica spin-column-based protocol, and includes enzymatic removal of residual DNA. The RNeasy DSP FFPE Kit is intended for in vitro diagnostic use. | The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream applications. | Class II | Terminated | |
| Z-0383-2019 | EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL. | An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Qiagen edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain