BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)

    Recall: Z-2874-2020 · Initiated July 13, 2020

    Recall

    Recall Number
    Z-2874-2020
    Event Number
    86070
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305840
    Product Code
    CIG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 13, 2020
    Terminated
    July 27, 2021
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)

    Reason

    Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

    Action

    Ortho Clinical Diagnostics issued URGENT PRODUCT CORRECTION NOTIFICATION on 13 July 2020, customer letter (Ref. CL2018-181) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received one of the affected products in the previous 18 months. Foreign affiliates were informed by email on 13 July 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available. Letter states reason for recall, health risk and action to take: Instruction for Use will be update at a later date to indicate Eltrombopag as a known interferent. REQUIRED ACTIONS " Follow your normal laboratory procedures as you would for other known interferences." Complete the enclosed Confirmation of Receipt form no later than July 21, 2020. " Please forward this notification if the product was distributed outside of your facility. " Save this notification with your user documentation Questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

    Quantity

    80351:US=35113; OUS: OUS=1593941.1612365: US=20068; OUS= 35534