BEUDAMED
    FDA Recall Terminated

    MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run

    Recall: Z-1956-2018 · Initiated May 2, 2018

    Recall

    Recall Number
    Z-1956-2018
    Event Number
    79899
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    JJH
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    May 2, 2018
    Terminated
    April 30, 2019
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run

    Reason

    Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.

    Action

    Customers were notified of the field action by letter on 4/27/18. The letter included the following required actions: " If you used the MagNA Pure 24 Pathogen 200 and/or Pathogen 1000 protocols to extract nucleic acids for an assay for a chronic infectious disease (e.g., Hepatitis C Virus), then suspected false positives should be evaluated further following local procedures and retested as necessary. " Complete the attached fax form and fax it to 1-844-861-6232 or email it to [email protected]. " File this Urgent Medical Device Correction (UMDC) for future reference.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.

    Quantity

    163 units