BEUDAMED
    FDA Enforcement Class II Terminated

    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.

    Recall: Z-2418-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2418-2017
    Event ID
    77026
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2017
    Initiation Date
    April 20, 2017
    Classification Date
    June 13, 2017
    Termination Date
    July 22, 2020
    Address
    595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States

    Description

    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.

    Reason

    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

    Code Info

    5890166203 11/May/18 5890175203 20/May/18 5890208103 22/Jun/18 5890229103 13/Jul/18 5890230103 14/Jul/18 5890250203 03/Aug/18 5890251203 04/Aug/18 5890257203 10/Aug/18 5890258203 11/Aug/18 5890259203 12/Aug/18 5890262103 15/Aug/18 5890265203 18/Aug/18 5890270103 23/Aug/18 5890278103 31/Aug/18 5890279103 01/Sep/18 5890286103 08/Sep/18 5890286203 08/Sep/18 5890292103 14/Sep/18

    Distribution

    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.

    Quantity

    48,371 cartons