BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    Recall: Z-1556-2013 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1556-2013
    Event ID
    64874
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 26, 2013
    Initiation Date
    April 1, 2013
    Classification Date
    June 18, 2013
    Termination Date
    March 22, 2017
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States

    Description

    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    Reason

    The firm is recalling the specific lot due to lower than expected results.

    Code Info

    Lot # 1529-17-2636, expiration date 12 June 2013

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.

    Quantity

    478 total (339- Domestic) (139- International)