BEUDAMED
    FDA Recall Terminated

    NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.

    Recall: Z-2342-2016 · Initiated July 8, 2016

    Recall

    Recall Number
    Z-2342-2016
    Event Number
    74761
    Firm
    BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
    FEI Number
    1000611339
    Product Code
    LDT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 8, 2016
    Posted
    August 9, 2016
    Terminated
    March 10, 2022

    Description

    NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.

    Reason

    Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.

    Action

    Consignees were notified of the recall by letter on July 18, 2016. The letter informed them of what actions need to be taken if they experience problems. The letter included a reply form to be returned. Subsidiaries and distributors were notified electronically on 7/8/2016.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, and the countries of Angola, Argentina, Austria, Australia, Austria, Botswana, Brazil, Burkina Faso, Cambodia, China, Colombia, Djibouti Antilles, Estonia, Georgia, Germany, Greece, India, Israel, Italy, Kuwait, Latvia, Malaysia, Mexico, Netherlands, Poland, Qatar, Russia, Senegal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Zambia, and Zimbabwe

    Quantity

    7,845 units