Reported Apr 17, 2024 · Ongoing

EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic…

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?

  • EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications
  • Model Number9003230
Lot codes and dates
  • GTIN04053228040576
  • US
    • P0722011M
    • P0123035M
    • P0323027M
    • P0623016M
    • P0823004M
    • P0823051M
    • P0523120M
    • P0323035M
    • P0423054M
    • P0523114M
    • P0823039M
    • P0623013M
    • P0323028M
    • P0722022M
    • P0223019M
    • P1222015M
    • P1222040M
    • P0523110M
    • P0523097M
    • P0623014M
    • P1022066M
    • P1022069M
    • P1022074M
    • P0523106M
    • P0423039M
    • P1123016M
    • P0423056M
    • P0523098M
    • P0823050M
    • P0623008M
    • P0223014M
    • P0323038M
    • P0123038M
    • P0623015M
    • P1022065M
  • P0623017M P0722007M P0523118M ROW

    130 of 130 codes

    • P0823002M
    • P0223022M
    • P1022073M
    • P0923045M
    • P1123027M
    • P1222012M
    • P0223012M
    • P0123082M
    • P0823038M
    • P0722003M
    • P0523116M
    • P0523112M
    • P0523119M
    • P0523111M
    • P1123003M
    • P1123001M
    • P1123031M
    • P1022067M
    • P0523104M
    • P1222039M
    • P0923042M
    • P1123033M
    • P0923050M
    • P0323034M
    • P0223008M
    • P0623012M
    • P0223010M
    • P0623005M
    • P0623004M
    • P0623001M
    • P0623010M
    • P0223016M
    • P0223017M
    • P0623011M
    • P0623007M
    • P0223023M
    • P0223026M
    • P0223009M
    • P0123081M
    • P0423040M
    • P1123025M
    • P1022064M
    • P0323029M
    • P0223021M
    • P0523115M
    • P1123023M
    • P0323024M
    • P1123026M
    • P0722023M
    • P0823049M
    • P0323036M
    • P0923044M
    • P0823042M
    • P0423058M
    • P0623006M
    • P0823052M
    • P0623003M
    • P0323031M
    • P1222014M
    • P0223011M
Amount recalled
168 units: 38 units US; 130 units OUS

Where it was sold

  • Nationwide
  • DE

Why it was recalled

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

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, 5:38 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.