BEUDAMED
    FDA Enforcement Class II Ongoing

    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

    Recall: Z-1188-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1188-2021
    Event ID
    87319
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 17, 2021
    Initiation Date
    February 3, 2021
    Classification Date
    March 8, 2021
    Address
    500 Gbc Dr, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

    Reason

    Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.

    Code Info

    Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the countries of Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, SA, Slovakia, Slovenia, Spain, Switzerland.

    Quantity

    4174 devices (Domestic: 2836 devices, Foreign: 1338 devices)