BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products COCM Reagent

    Recall: Z-0817-2014 · Initiated October 4, 2013

    Recall

    Recall Number
    Z-0817-2014
    Event Number
    66474
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    DIO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 4, 2013
    Posted
    January 23, 2014
    Terminated
    May 17, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products COCM Reagent

    Reason

    Inaccurate quality control results.

    Action

    On October 4, 2013 Ortho Clinical Diagnostics issued a Product Correction Notification to customers via US Postal Service Priority Mail or FedEx regarding VITROS Chemistry Products COCM Reagent due to inaccurate quality control results. Ortho Clinical Diagnostics advised their customers to discontinue use and discard any recalled product. OCD customers with questions should be contact Customer Technical Services at 1-800-421-3311.

    Distribution

    Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.

    Quantity

    3,342 units