BEUDAMED
    FDA Recall Terminated

    VITEK 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton.

    Recall: Z-2526-2017 · Initiated April 20, 2017

    Recall

    Recall Number
    Z-2526-2017
    Event Number
    77026
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 20, 2017
    Posted
    May 22, 2017
    Terminated
    July 22, 2020
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    VITEK 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 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).

    Action

    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.

    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

    945 cartons