RegWardenFDA facility compliance records
Facility

QIAGEN

20 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2016: 1 recalls, 2 inspections, 1 warning letters; 2018: 2 recalls; 2019: 3 recalls; 2020: 5 recalls; 2021: 3 recalls, 1 inspections; 2022: 2 recalls; 2023: 1 recalls; 2024: 2 recalls; 2025: 1 recalls42016201722018320195202042021220221202322024120252026
  • Recalls (20)
  • Inspections (3)
  • Warning letters (1)

Devices registered here (1)

  • Applicator, Absorbent Tipped, Sterile
    Product code KXG (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6025

Recalls & enforcement

20251 record
  • Class IIOngoing2025-03-12
    Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
20242 records
  • Class IIOngoing2024-06-03
    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 (G…
  • Class IIOngoing2024-03-04
    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
20231 record
20222 records
  • Class IIOngoing2022-07-20
    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-can…
  • Class IIOngoing2022-02-25
    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.
20213 records
  • Class IIOngoing2021-11-21
    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 improperl…
  • Class IITerminated2021-11-08
    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 IITerminated2021-01-15
    QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
20205 records
  • Class IITerminated2020-12-11
    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 IITerminated2020-07-15
    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 IITerminated2020-04-08
    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 IITerminated2020-02-21
    An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
  • Class IITerminated2020-01-28
    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 suspe…
20193 records
  • Class IIOngoing2019-07-02
    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 cou…
  • Class ITerminated2019-06-05
    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 IITerminated2019-05-06
    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.
20182 records
  • Class IITerminated2018-07-23
    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 caus…
  • Class ITerminated2018-05-18
    Potential for control line not appearing on the test strip
20161 record

FDA inspections (3)

  • NAI2021-07-16
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2016-12-19
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2016-02-05
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “QIAGEN (FEI 3003572099) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003572099-qiagen/

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