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QIAGEN Sciences LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000014502

QIAGEN Sciences LLC is a medical device manufacturer based in the United States, with 46 devices listed in EUDAMED and FDA GUDID (FDA Class III; EU IVD General, Class A and Class C) and 23 FDA recalls as of 13 Nov 2026.

Devices
46
Registrations
EUDAMED
FDA recalls
2310 ongoing since 2021 (11 open in total)
1 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 24
  • FDA GUDID 24

A device listed in two registries counts in both.

Device classes
  • FDA Class III 18
  • EU IVD General 15
  • EU Class A 5
  • EU Class C 3
  • FDA Class II 3
  • EU Class I 1
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000014502

At a glance

Counted by deviCERTS from registry records

EU certificates

3 of 3 in force.

See certificates

Market reach

European Union
EUDAMED actor, 3 certificates
United States
FDA recalls
Authorised rep.
QIAGEN GmbHDE

Catalogue46

Newest first, rows 1-46 of 46

Search and filter all 46 devices
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Rows 1-46 of 46

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000014502
EU VAT number
DE295552899
EUDAMED status
Active
EUDAMED registered name
QIAGEN Sciences LLC
Registered address
19300, Germantown Road, MD 20874, Germantown, United States
Phone
+12406867700
PRRC contact
Donna Sowers(public in EUDAMED)

EUDAMED certificates3

3 certificates3 valid, 0 expiredIVDR 3next expiry 9 Sep 2029

EUDAMED certificates (3)

TÜV Rheinland LGA Products GmbH 0197 3 certificates

  • IX 1545122-2 Active

    Technical documentation EU IVDR

    Issued
    10 Nov 2025
    Expires
    9 Nov 2030
  • HX 1545122-1 Active Supplemented

    Quality management system EU IVDR

    Issued
    3 Feb 2026
    Expires
    9 Sep 2029
    Reason
    Add device or group
  • IX 1545122-1 Active

    Technical documentation EU IVDR

    Issued
    10 Sep 2024
    Expires
    9 Sep 2029

FDA recalls23

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 2
  • 2019 3
  • 2020 5
  • 2021 3
  • 2022 5
  • 2023 1
  • 2024 2
  • 2025 1
  • 2026 0

1 initiated before 2017

Showing the 10 most recent of 23 recalls.

  • 2025

    • 12 Mar 2025 Z-1504-2025 Class II Ongoing Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. Distribution: US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX. Submission number: K233100

  • 2024

    • 3 Jun 2024 Z-2353-2024 Class II Ongoing 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. Distribution: Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO,…
      Full distribution text Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI
    • 4 Mar 2024 Z-1508-2024 Class II Ongoing 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 Distribution: Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH

  • 2023

    • 28 Apr 2023 Z-1683-2023 Class II Ongoing Faulty cartridges in the lot could result in false test results. Distribution: US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

  • 2022

    • 20 Jul 2022 Z-1650-2022 Class II Ongoing 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 Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand Submission number: P180043
    • 20 Jul 2022 Z-1651-2022 Class II Ongoing 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 Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand Submission number: P180043
    • 20 Jul 2022 Z-1652-2022 Class II Ongoing 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 Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand Submission number: P180043
    • 25 Feb 2022 Z-0951-2022 Class II Ongoing 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. Distribution: AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV Submission number: P110027
    • 25 Feb 2022 Z-0952-2022 Class II Ongoing 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. Distribution: AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV Submission number: P110027

  • 2021

    • 21 Nov 2021 Z-1746-2022 Class II Ongoing 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. Distribution: Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA,…
      Full distribution text Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.
Show all 23 recalls

  • 2021

    • 8 Nov 2021 Z-0455-2022 Class II Terminated 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. Distribution: Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
    • 15 Jan 2021 Z-0941-2021 Class II Terminated QIAGEN has become aware of the potential for false positive results to occur with some patient samples. Distribution: Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY

  • 2020

    • 11 Dec 2020 Z-0937-2021 Class II Terminated 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. Distribution: CA, IN, MI, MN, NC, NJ, NM, OH, TX Submission numbers: P190001, P190004
    • 15 Jul 2020 Z-2938-2020 Class II Terminated 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. Distribution: US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY,…
      Full distribution text US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.
    • 8 Apr 2020 Z-2290-2020 Class II Terminated 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. Distribution: US Nationwide. Submission number: P120022
    • 21 Feb 2020 Z-1636-2020 Class II Terminated An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute. Distribution: Nationwide domestic distribution. Foreign distribution to Canada. Submission number: K081767
    • 28 Jan 2020 Z-1476-2020 Class II Terminated 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 Distribution: Worldwide distribution - US Nationwide distribution and countries Afghanistan, Algeria, Argentina, Armenia, Australia,…
      Full distribution text Worldwide distribution - US Nationwide distribution and countries Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macao, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mayotte, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory Occupied, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia,…
      Submission number: K113319

  • 2019

    • 2 Jul 2019 Z-2319-2019 Class II Open since 2019 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 Distribution: Worldwide Distribution - US Nationwide Foreign: Algeria Australia Austria Azerbaijan Belgium Brazil Canada China Czech…
      Full distribution text Worldwide Distribution - US Nationwide Foreign: Algeria Australia Austria Azerbaijan Belgium Brazil Canada China Czech Republic Denmark Finland France Germany Greece India Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Mexico Netherlands Norway Pakistan Poland Republic of Korea Russian Federation Singapore South Africa Spain Sweden Switzerland Thailand Turkey United Kingdom
    • 5 Jun 2019 Z-2088-2019 Class I Terminated 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) Distribution: US Nationwide distribution
    • 6 May 2019 Z-1891-2019 Class II Terminated 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. Distribution: US nationwide distribution in the states of MA, RI, AZ, NY, NC, IN, TX. The products were distributed to the following…
      Full distribution text US nationwide distribution in the states of MA, RI, AZ, NY, NC, IN, TX. The products were distributed to the following foreign countries: Germany, Great Britain, Italy, France, Sweden, and Switzerland.
      Submission number: P180043

  • 2018

    • 23 Jul 2018 Z-0383-2019 Class II Terminated 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. Distribution: Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alger, Argentina, Australia, Austria, Canada, China, Dubai, Egypt, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Korea, Latvia, Mexico, Morocco, Norway, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, UK.
    • 18 May 2018 Z-2577-2018 Class I Terminated Potential for control line not appearing on the test strip Distribution: Worldwide - US Nationwide distribution an in the country of , Canada Submission number: K081767

  • 2016

    • 2 Feb 2016 Z-1230-2016 Class II Terminated Potential for obtaining a false positive result due to the possibility of endotoxin presence. Distribution: Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium,…
      Full distribution text Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
      Submission number: P010033

From the company website

Read 18 Sep 2026

At QIAGEN, we don’t wait – we make it possible. We roll up our sleeves, think differently and work side by side to make improvements in life possible.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does QIAGEN Sciences LLC have in the registry?

The registry currently lists 46 devices for QIAGEN Sciences LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list QIAGEN Sciences LLC's devices?

Among its 46 most recently registered devices, QIAGEN Sciences LLC has devices listed in EUDAMED (24 devices) and FDA GUDID (24 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do QIAGEN Sciences LLC's devices fall under?

Among its 46 most recently registered devices, the classes recorded for QIAGEN Sciences LLC's devices are Class I, Class II, Class III, IVDR Class A, IVDR Class C and IVD general. Each device page shows its own class and authorisation.

Are there FDA recall records for QIAGEN Sciences LLC?

FDA recall records list 23 recalls initiated by QIAGEN Sciences LLC, the most recent initiated on 12 Mar 2025. 11 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for QIAGEN Sciences LLC?

EUDAMED lists 3 certificates for QIAGEN Sciences LLC (technical documentation; quality management system) under IVDR. 2 are recorded with the status issued. The most recent was issued on 3 Feb 2026.

What are the newest devices from QIAGEN Sciences LLC in the registry?

The most recently registered devices listed for QIAGEN Sciences LLC include digene HC2 HPV DNA Test, Hybrid Capture System Multi-Specimen Tube (MST) Vortexer 2, Hybrid Capture System Microplate Heater 1 and AmniSure ROM Test.

Generated automatically from registry data and not verified by a human reviewer.