BEUDAMED
    FDA Enforcement Class II Terminated

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    Recall: Z-1735-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1735-2013
    Event ID
    65088
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Paa Laboratories Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    April 12, 2013
    Classification Date
    July 15, 2013
    Termination Date
    September 14, 2015
    Address
    145 Bethridge Road, N/A, Etobicoke, Ontario, N/A, Canada

    Description

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    Reason

    Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of Un

    Code Info

    510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)

    Distribution

    Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada

    Quantity

    approximately 280,000 liters