BEUDAMED
    FDA Enforcement Class II Terminated

    NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.

    Recall: Z-1365-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1365-2020
    Event ID
    84766
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BIOMERIEUX - Grenoble
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2020
    Initiation Date
    January 10, 2020
    Classification Date
    February 26, 2020
    Termination Date
    April 14, 2022
    Address
    Biomerieux, Institut Christophe Merieux; 5 Rue Des Berges; Cs 30076, Grenoble Cedex 1, N/A, N/A, France

    Description

    NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.

    Reason

    Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201. The issue is linked to drift of pH electrode dysfunction.

    Code Info

    Lot 19040201, Expiry 28-Feb-2021

    Distribution

    No US distribution. No Mexican consignees. International distribution to South Africa, Uruguay, Tanzania, Romania, Netherlands, Macao, Italy, India, Hong Kong, United Kingdom, France, Spain, Germany, China, Chile, Canada, Belgium, Australia, Argentina, Curacao.

    Quantity

    1024