RegWardenFDA facility compliance records
Company

QIAGEN, GmbH

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2018: 1 recalls; 2023: 3 recalls1201712018201920202021202232023202420252026
  • Recalls (5)

Registered facilities (2)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “QIAGEN, GmbH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9065957-qiagen-gmbh/

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