BEUDAMED
    FDA Recall Terminated

    bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134

    Recall: Z-0443-2019 · Initiated October 8, 2018

    Recall

    Recall Number
    Z-0443-2019
    Event Number
    81323
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    PPM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 8, 2018
    Terminated
    May 21, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134

    Reason

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

    Action

    Required Actions We request you to take the following actions at this time: -Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. -Stop using the NUCLISENS Lysis Buffer, Ref. 280134, Lot: Z019EA1LB, exp. 28-MAY-2019, and destroy any stock of this lot Z019EA1LB you might have in your laboratory. -Discuss any concern you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. -Contact your local bioMerieux, Inc. Customer Service representative if you have observed the issue and if you have a doubt regarding your results. -Complete the attached Acknowledgement Form in Attachment A to confirm receipt of this notice and return it to your local bioMrieux, Inc. representative. bioMrieux, Inc. is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused your business. If you require additional assistance or have any questions, please contact your local bioMrieux, Inc. Clinical Customer Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656. For non-urgent inquiries, please contact the Clinical Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM 7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.

    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