BEUDAMED
    FDA Enforcement Class II 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 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2874-2020
    Event ID
    86070
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 2, 2020
    Initiation Date
    July 13, 2020
    Classification Date
    August 24, 2020
    Termination Date
    July 27, 2021
    Address
    513 Technology Blvd, N/A, Rochester, NY, 14626-3601, United States

    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

    Code Info

    All Current, Future and Past Lots UDI: 10758750004829, 10758750009398

    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