BEUDAMED
    FDA Enforcement Class II Terminated

    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    Recall: Z-0841-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0841-2014
    Event ID
    66931
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux France Chemin De L'Or
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 5, 2014
    Initiation Date
    November 8, 2013
    Classification Date
    January 27, 2014
    Termination Date
    November 30, 2017
    Address
    Chemin De L'Orme, Marcy L'Etoile, N/A, France

    Description

    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    Reason

    bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

    Code Info

    Lot numbers: 1002171010, 1002295110, 1002360360, 1002421440, 1002485410, 1001951820, 1002011320, and 1002071020.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe

    Quantity

    39439 kits (includes ZYM B reagents, API Listeria * API NH kits)