BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

    Recall: Z-0844-2021 · Initiated December 15, 2020

    Recall

    Recall Number
    Z-0844-2021
    Event Number
    87019
    Firm
    Ortho Clinical Diagnostics Inc
    FEI Number
    2250051
    Product Code
    CEK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 15, 2020
    Terminated
    July 27, 2021
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424

    Description

    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

    Reason

    Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

    Action

    Ortho-Clinical Diagnostics (Ortho) issued customer letter (Ref. CL2018-308) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) on 15 Dec 2020 to all customers who received one of the affected products in the previous 18 months. Letter states reason for recall, health risk and action to take: Complete the enclosed Confirmation of Receipt form no later than insert date. Please provide the enclosed communication to customers who were shipped the affected products (listed above) from your facility within the last 18 months. Ortho has communicated with your customers that received drop shop product from our warehouse. Foreign affiliates were informed by email on 15 Dec 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.

    Quantity

    US= 223,788 ; OUS:=168,120 Totlal: 491,908