BEUDAMED
    FDA Enforcement Class II Terminated

    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

    Recall: Z-2280-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2280-2018
    Event ID
    80211
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    May 22, 2018
    Classification Date
    June 22, 2018
    Termination Date
    November 17, 2020
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

    Reason

    The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.

    Code Info

    All lots.

    Distribution

    Distributed to accounts in CA, IN, KS, ME, and WV, and PR. Foreign distribution to Australia, Bangladesh, Belarus, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Cyprus, Denmark, Dutch Caribbean, Ecuador, Egypt, El Salvador, Ethiopia, Falkland Islands, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Italy, Jordan, Kenya, Saudi Arabia, Korea, Kuwait, Latvia, Lebanon, Peru, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Morocco, Myanmar, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Oman, Thailand, Netherlands, Turkey, United Arab Emirates, United Kingdom, Ukraine, Vietnam, and Zimbabwe.