BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)

    Recall: Z-0476-2019 · Initiated October 8, 2018

    Recall

    Recall Number
    Z-0476-2019
    Event Number
    81376
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    MRR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 8, 2018
    Terminated
    October 13, 2022
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)

    Reason

    VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

    Action

    Ortho Clinical Diagnostics issue the customer notification on October 8, 2018, provides information regarding the potential for biased results when using VITROS dLDL Reagent, Generations (GENs) 26 and 27. Actions to take: For GEN 26: Discontinue using GEN 26 and switch to an alternate GEN of product as soon as possible. Please specify full or partial sales units remaining and indicate credit or replacement on your Confirmation of Receipt form. " For GEN 27: Install ADD DRV 6003 on your VITROS System upon receipt. Following a successful recalibration, resume using VITROS dLDL Reagent, GEN 27 remaining in your inventory. " Complete the Confirmation of Receipt form and return by October 22, 2018. Questions contact our Ortho Care" Technical Solutions Center at 1-800-421-3311

    Distribution

    Nationwide Foreign: Australia Belgium Bermuda, HM11 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Poland Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom

    Quantity

    5850 units