Drugs & medicalClass II

Qiagen Sciences LLC recalls EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular…

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

Read the official notice →
Date
2024-04-17
Country
United States
Brand
Qiagen Sciences
Product
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular…
Classification
Class II
Units
Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Qiagen Sciences recalls

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  3. 2024-07-24
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    Qiagen Sciences LLC recalls QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic…

    Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA…

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  5. 2023-06-14
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    Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

    Faulty cartridges in the lot could result in false test results.

    FDA · DeviceQiagen Sciences LLCUS Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.Official notice →
  7. 2022-09-21
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    Qiagen Sciences LLC recalls QIAcube Connect MDx, Model No. 9003070

    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…

    FDA · DeviceQiagen Sciences LLCDomestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN,…Official notice →
  9. 2022-09-07
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    Qiagen Sciences LLC recalls FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

    Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the…

    FDA · DeviceQiagen Sciences LLCIN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands,…Official notice →
  11. 2022-04-27
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    Qiagen Sciences LLC recalls therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

    False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

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All 8 Qiagen Sciences recalls →

Other drugs & medical recalls in the United States

  1. 2024-04-17
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    Intuitive Surgical, Inc. recalls Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

    Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries,…

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