BEUDAMED
    FDA Recall Terminated

    VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.

    Recall: Z-1489-2021 · Initiated March 26, 2021

    Recall

    Recall Number
    Z-1489-2021
    Event Number
    87649
    Firm
    Ortho-Clinical Diagnostics, INc.
    FEI Number
    1000305840
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 26, 2021
    Terminated
    May 24, 2023
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.

    Reason

    Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.

    Action

    On 3/25/2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice via letter notifying customers two lots of the VITROS Black Reference Slides have the incorrect part number on the box.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV, WY and the countries of Australia, Bermuda, Brazil, Canada, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.

    Quantity

    865 units of 25 slides each