BEUDAMED
    FDA Enforcement Class II Terminated

    bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

    Recall: Z-0443-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0443-2019
    Event ID
    81323
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 21, 2018
    Initiation Date
    October 8, 2018
    Classification Date
    November 9, 2018
    Termination Date
    May 21, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402, United States

    Description

    bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

    Reason

    Some eluates become colored because of remaining hemoglobin in the eluate.

    Code Info

    Lot Z019EA1LB Exp. 28-MAY-2019.

    Distribution

    CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh

    Quantity

    268