BEUDAMED
    FDA Enforcement Class II Terminated

    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    Recall: Z-1478-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1478-2014
    Event ID
    67820
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    March 6, 2014
    Classification Date
    April 18, 2014
    Termination Date
    March 14, 2017
    Address
    Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, N/A, France

    Description

    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    Reason

    bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent

    Code Info

    Code - 1002569040, Exp. Date 8/29/2014, 1002569041, Exp. Date 8/296/2014, 1002587190, Exp. Date 9/3/2014, 1002856790, Exp. Date 7/18/2014, 1002856800, Exp. Date 6/12/2014

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

    Quantity

    33,853