BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

    Recall: Z-2405-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2405-2020
    Event ID
    85687
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2020
    Initiation Date
    May 7, 2020
    Classification Date
    June 19, 2020
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

    Reason

    Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

    Code Info

    Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL

    Distribution

    Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.

    Quantity

    1329