Facility

QIAGEN, GMBH

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004013603
Establishment type	Manufacture Medical Device
Location	QIAGEN STRASSE 1 HILDEN North Rhine-Westphalia, DE 40724
Registration status	Active · expires 2026
Parent company	QIAGEN, GmbH (owner-operator 9065957)
Brand names	therascreen® FGFR RGQ RT-PCR Kit

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Somatic Gene Mutation Detection System
Product code OWD (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2023-08-22
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 in…
Class IIOngoing2023-05-19
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Class IIOngoing2023-05-09
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 IITerminated2018-05-28
Underfilled reagent well that could lead to incorrect results
Class IITerminated2017-07-22
Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.

FDA inspections (2)

VAI2022-11-04
Voluntary Action Indicated · Project Evaluation: Devices
NAI2017-02-09
No Action Indicated · Compliance: Devices; Project Evaluation: Devices

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.

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, GMBH (FEI 3004013603) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004013603-qiagen-gmbh/

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