Data / Medical devices / United States / Qiagen
Qiagen: FDA-registered device maker in Germantown, MD, United States, 5 510(k) clearances and 3 PMA approvals
Qiagen is registered with the FDA (registration 1122376) in Germantown, MD, United States. It lists 12 device types. The FDA files 5 510(k) clearances and 3 PMA approvals under its listings, the newest dated April 11, 2018. 24 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1122376
- FEI number
- 3003572099
- Address
- 19300 Germantown Rd, Germantown, MD, United States, 20874
- Owner or operator
- QIAGEN Sciences LLC (9002668)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- October 25, 2001
- Registered through
- 2026
- Brand names listed
- AmniSure ROM Test Positive and Negative Controls Pack, AmniSure® ROM (Rupture of [fetal] Membranes) Test, Buffer AVL, DML 3000, IGRA Control Set, Lyophilized Anti-CD3, Lyophilized R848, PartoSure Test and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Dna-Reagents, Chlamydia | LSK | 1 | Manufacturer | accessdata.fda.gov |
| Dna-Reagents, Neisseria | LSL | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Immunoassay For Detection Of Amniotic Fluid Protein(S). | NQM | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Dna Detection, Human Papillomavirus | MAQ | 3 | Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Placental Alpha Microglobulin-1 Immunoassay | QBB | 3 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Spatula, Cervical, Cytological | HHT | 2 | Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Specification developer | accessdata.fda.gov |
| Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | NCD | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2009 | K081767 | AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 | NQM | Substantially Equivalent | Amnisure International, LLC | accessdata.fda.gov |
| February 2, 2004 | K030849 | AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 | JJX | Substantially Equivalent | N-Dia, Inc. | accessdata.fda.gov |
| November 29, 1999 | K981485 | HYBRID CAPTURE II GC-ID | LSL | Substantially Equivalent | Digene Corp. | accessdata.fda.gov |
| October 25, 1999 | K990023 | HYBRID CAPTURE II CT-ID TEST | LSK | Substantially Equivalent | Digene Corp. | accessdata.fda.gov |
| September 19, 1997 | K971586 | DIGENE CERVICAL BRUSH | HHT | Substantially Equivalent | Digene Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 11, 2018 | P160052 | PartoSure test | QBB | 1 | October 11, 2019 | accessdata.fda.gov |
| November 28, 2001 | P010033 | QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE | NCD | 49 | October 14, 2026 | accessdata.fda.gov |
| March 11, 1991 | P890064 | VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT | MAQ | 37 | October 19, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 12, 2025 | 96521 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 3, 2024 | 94836 | Class II | Ongoing | 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: | 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 err | accessdata.fda.gov |
| March 4, 2024 | 94254 | Class II | Ongoing | 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 | accessdata.fda.gov |
| April 28, 2023 | 92298 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 20, 2022 | 90691 | Class II | Ongoing | 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 | accessdata.fda.gov |
| February 25, 2022 | 89914 | Class II | Ongoing | 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. | accessdata.fda.gov |
| November 21, 2021 | 90758 | Class II | Ongoing | 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 res | accessdata.fda.gov |
| November 8, 2021 | 89130 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 15, 2021 | 87205 | Class II | Terminated | SARS-CoV-2 Antigen Test | QIAGEN has become aware of the potential for false positive results to occur with some patient samples. | accessdata.fda.gov |
| December 11, 2020 | 87047 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 15, 2020 | 86149 | Class II | Terminated | 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 organism | 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. | accessdata.fda.gov |
| April 8, 2020 | 85565 | Class II | Terminated | 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. | accessdata.fda.gov |
| February 21, 2020 | 85122 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 28, 2020 | 85004 | Class II | Terminated | 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 | accessdata.fda.gov |
| July 2, 2019 | 83409 | Class II | Ongoing | 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 QIAsy | 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 | accessdata.fda.gov |
| June 5, 2019 | 83199 | Class I | Terminated | 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) | accessdata.fda.gov |
| May 6, 2019 | 82985 | Class II | Terminated | 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 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. | accessdata.fda.gov |
| July 23, 2018 | 80862 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| May 18, 2018 | 80404 | Class I | Terminated | AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of am | Potential for control line not appearing on the test strip | accessdata.fda.gov |
| February 2, 2016 | 73384 | Class II | Terminated | QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease) | Potential for obtaining a false positive result due to the possibility of endotoxin presence. | accessdata.fda.gov |
| January 30, 2013 | 64650 | Class II | Terminated | QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time | CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. | accessdata.fda.gov |
| January 12, 2011 | 57814 | Not yet classified | Terminated | Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interpre | The software component of a diagnostic medical device may be defective and could cause incorrect patient values. | accessdata.fda.gov |
| May 28, 2004 | 29292 | Not yet classified | Terminated | Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003. | In vitro diagnostic test kit may produce false negative clinical results. | accessdata.fda.gov |
| February 7, 2003 | 25678 | Not yet classified | Terminated | Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096 | In Vitro diagnostic test kit may produce false positive patient results | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Dna-Reagents, Neisseria
- All makers of Immunoassay For Detection Of Amniotic Fluid Protein(S).
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Reagents, Specific, Analyte
Updated March 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.