BEUDAMED
    FDA Recall Terminated

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    Recall: Z-1476-2020 · Initiated January 28, 2020

    Recall

    Recall Number
    Z-1476-2020
    Event Number
    85004
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    OOI
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    January 28, 2020
    Terminated
    September 26, 2024
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    Description

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    Reason

    When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment

    Action

    QIAGEN issued Urgent Medical Device Correction via email on 1/28/20 advising reason for recall, health risk and action to take: 1) Discontinue use of the Rotor-Gene Q instrument in the following specific conditions: The Rotor-Gene Q instrument is running Software 2.3.4 using the export function to LIMs 2) Upgrade to the latest version of the RGQ software which resolves the issue version 2.3.5. This is expected to be available on 1st February 2020. Please visit the QIAGEN website to upgrade: www.qiagen.com/resources/resourcedetail?id=9d8bda8e-1fd7-4519-a1ff-b60bba526b57&lang=en. Apart from correcting this fault, no other changes to the software have been implemented. Laboratory personnel and clinicians are advised to consider a patients previous test results, other diagnostic tests, anamnesis and current clinical condition when interpreting results from this software. If the results do not match the patients clinical presentation, or incongruences are found with previous and concomitant tests or the results are otherwise unexpected, the patient sample should be retested using an alternate test method or a reference laboratory. 3) Complete the Acknowledgement of Receipt form and return it to QIAGEN. If you have further questions, please contact QIAGEN Technical Services Department on 800-362-7737 (US & Canada) " QIAGEN Subsidiaries: https://www.qiagen.com/about-us/contact/global-contacts/subsidiaries/ " QIAGEN Commercial Partners and Importers: https://www.qiagen.com/about-us/contact/global-contacts/distributors-and-importers/

    Distribution

    Worldwide distribution - US Nationwide distribution and countries Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macao, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mayotte, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory Occupied, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab, Republic of Taiwan, Tajikistan, Thailand, Timor-Leste (else known as East Timor), Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic of, Viet Nam, Yemen.

    Quantity

    11418 instruments