Reported Sep 21, 2022 · Ongoing

QIAcube Connect MDx, Model No. 9003070

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?

  • QIAcube Connect MDx, Model No. 9003070
Lot codes and dates
  • UDI-DI (GTIN)04053228039129 Serial Numbers (U.S.)

    91 of 91 codes

    • 30000
    • 30009
    • 30027
    • 30039
    • 30049
    • 30061
    • 30073
    • 30002
    • 30010
    • 30028
    • 30041
    • 30050
    • 30062
    • 30075
    • 30003
    • 30132
    • 30031
    • 30042
    • 30051
    • 30063
    • 30078
    • 30004
    • 30013
    • 30032
    • 30043
    • 30053
    • 30064
    • 30080
    • 30005
    • 30016
    • 30034
    • 30044
    • 30057
    • 30065
    • 30082
    • 30006
    • 30019
    • 30035
    • 30045
    • 30058
    • 30067
    • 30089
    • 30007
    • 30021
    • 30033
    • 30046
    • 30059
    • 30069
    • 30090
    • 30008
    • 30023
    • 30037
    • 30047
    • 30060
    • 30071
    • 30093
    • 30094
    • 30095
    • 30097
    • 30102
Amount recalled
93 US; 57 OUS

Where it was sold

Why it was recalled

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 improperly lysed sample, which in turn could lead to false negative or false positive results.

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, 4:52 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.