BEUDAMED
    FDA Enforcement Class II Terminated

    Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes

    Recall: Z-1093-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1093-2017
    Event ID
    76053
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acumedia Manufacturers, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 1, 2017
    Initiation Date
    April 22, 2016
    Classification Date
    January 25, 2017
    Termination Date
    September 19, 2018
    Address
    740 E Shiawassee St, N/A, Lansing, MI, 48912-1218, United States

    Description

    Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes

    Reason

    light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.

    Code Info

    7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B

    Distribution

    Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.

    Quantity

    482