Reported Apr 9, 2025 · Ongoing

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:…

Qiagen Sciences LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415

Is this the product you have?

  • Brand NameQIAstat-Dx
  • Product NameQIAstat-Dx Respiratory
  • Panel Plus Reference Number (REF)691224
  • Software Versionn/a
  • Componentn/a
Lot codes and dates
    • REF 691224
    • Lot 178038604
  • UDI-DI04053228047438
  • affected Serial numbers (SNs)

    200 of 200 codes

    • 332168961
    • 332168962
    • 332168963
    • 332168964
    • 332168972
    • 332168978
    • 332168979
    • 332168980
    • 332168990
    • 332168996
    • 332169005
    • 332169012
    • 332169013
    • 332169015
    • 332169016
    • 332169021
    • 332169022
    • 332169023
    • 332169024
    • 332169031
    • 332169032
    • 332169033
    • 332169034
    • 332169039
    • 332169040
    • 332169041
    • 332169042
    • 332169047
    • 332169048
    • 332169049
    • 332169050
    • 332169055
    • 332169056
    • 332169057
    • 332169060
    • 332169065
    • 332169066
    • 332169073
    • 332169074
    • 332169083
    • 332169084
    • 332169085
    • 332169086
    • 332169091
    • 332169092
    • 332169093
    • 332169094
    • 332169099
    • 332169101
    • 332169102
    • 332169107
    • 332169108
    • 332169109
    • 332169110
    • 332169115
    • 332169116
    • 332169117
    • 332169118
    • 332169123
    • 332169125
Amount recalled
445 units

Where it was sold

Why it was recalled

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.