The Recall Desk

Manufacturer

Qiagen Sciences LLC

21 recalls in our database name Qiagen Sciences LLC as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
2
Most recent
2025-04-09

Of the 21 recalls from Qiagen Sciences LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • HighFDA (Devices)·Z-1504-2025·2025-04-09

    Respiratory Diagnostic Cartridges Recalled for Risk of False Test Results

    Qiagen is recalling 445 QIAstat-Dx Respiratory Panel Plus cartridges due to faulty units that could produce false test results. Affected devices distributed to 12 US states should not be used.

    Product
    Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2353-2024·2024-07-24

    Qiagen QIAcube Connect MDx heating failure may cause erroneous diagnostic results

    A heating defect in the Qiagen QIAcube Connect MDx may prevent proper incubation temperatures below 40°C, potentially affecting diagnostic test results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2024·2024-04-17

    Nucleic Acid Isolation Device Recall: EZ2 Connect MDx-IVD Heater Failure

    Qiagen Sciences is recalling 168 units of the EZ2 Connect MDx-IVD nucleic acid isolation device due to insufficient welding that causes heater cable embrittlement and device malfunction, resulting in sample loss during testing.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2023·2023-06-14

    QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk

    Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2022·2022-09-21

    Laboratory device displays incorrect sample volume guidance during setup

    A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.

    Product
    QIAcube Connect MDx, Model No. 9003070
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1651-2022·2022-09-07

    therascreen FGFR RGQ Kit Recalled for Increased False Positive Results

    Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.

    Product
    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1652-2022·2022-09-07

    RT-PCR Kit Recalled Due to False Positive Test Results

    Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.

    Product
    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1650-2022·2022-09-07

    FGFR cancer diagnostic kit recalled due to increased false positive results

    Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.

    Product
    therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0952-2022·2022-04-27

    Qiagen therascreen KRAS RGQ PCR Kit Recall: False Positive/Negative Results

    Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.

    Product
    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0951-2022·2022-04-27

    Genetic Testing Kit Recalled for Inaccurate Mutation Test Results

    Qiagen Sciences' KRAS mutation testing kit can produce false positive or false negative results due to testing flags or warnings. 435 kits distributed across 16 U.S. states are affected.

    Product
    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0455-2022·2022-01-12

    COVID-19 Diagnostic Kit Recall for Inaccurate Test Results

    Qiagen Sciences is recalling 376 units of its QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kit due to faulty cartridges that can produce false-negative or false-positive test results.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0937-2021·2021-02-03

    Qiagen Recalls PIK3CA PCR Kits Due to False Positive Mutation Results

    Qiagen Sciences LLC is recalling 575 therascreen PIK3CA RGQ PCR Kits because they may generate false positive results for the Q546R mutation, potentially affecting treatment decisions for breast cancer patients.

    Product
    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
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2938-2020·2020-09-16

    Qiagen SARS-CoV-2 Test Panel Recalled for Influenza A False Positives

    Qiagen is recalling 1,474 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to an increased rate of false positive results for Influenza A, which may lead to inappropriate antiviral use or delayed diagnosis.

    Product
    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 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2290-2020·2020-06-17

    Qiagen Recalls EGFR PCR Kits Due to False Positive Risk

    Qiagen is recalling 530 therascreen EGFR RGQ PCR Kits because a fluorescence artifact can cause rare false mutation positive results.

    Product
    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1636-2020·2020-04-08

    Qiagen AmniSure ROM Test Recalled for Incorrect Rinse Time Labeling

    Qiagen Sciences LLC is recalling AmniSure ROM Test kits because the packaging displays an incorrect rinse time of 30 seconds instead of the correct 1 minute.

    Product
    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)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1476-2020·2020-03-18

    Qiagen Rotor-Gene Q Software Recall for Incorrect Concentration Reporting

    Qiagen is recalling Rotor-Gene Q instruments with software version 2.3.4 because a bug causes concentration results to be reported as logarithmic values, potentially leading to false negative test results.

    Product
    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2319-2019·2019-08-28

    Qiagen QIAsymphony SP Software 5.0.3 Recalled for Barcode Assignment Error

    Qiagen is recalling QIAsymphony SP software version 5.0.3 because it incorrectly assigns 2D barcode eluate IDs to samples, which could lead to incorrect patient reporting.

    Product
    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 p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2088-2019·2019-08-07

    Qiagen Filter-Tips Recalled for Leaking During Sample Preparation

    Qiagen Sciences LLC is recalling specific lots of Filter-Tips used with QIAsymphony instruments because a small percentage of tips are leaking.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2019·2018-11-14

    Qiagen EZ1 Advanced XL Recalled for Potential Heater Malfunction

    Qiagen is recalling 298 EZ1 Advanced XL instruments due to a power board defect that may cause heater malfunctions and compromise nucleic acid extractions.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2016·2016-03-30

    Qiagen QFT TB Antigen Tubes Recalled for Potential Endotoxin Contamination

    Qiagen is recalling QFT TB Antigen Tubes due to potential endotoxin presence that could cause false positive results in tuberculosis tests.

    Product
    QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

QIAGEN SCIENCES, LLC

Source: Wikidata (Q140192947), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.