BEUDAMED
    FDA Enforcement Class II Terminated

    Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

    Recall: Z-2283-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2283-2020
    Event ID
    85602
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    May 4, 2020
    Classification Date
    June 5, 2020
    Termination Date
    September 20, 2021
    Address
    500 Gbc Dr, N/A, Newark, DE, 19702-2466, United States

    Description

    Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

    Reason

    The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

    Code Info

    Lot #s 100051, 100025, 100002, 190294, 190256, 190200, 190171, 190135, 190126 ***Added 9/9/20*** 100087 ***Added 11/2/20*** 100109 100136 100167 ***Added 3/11/21*** 110032

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesota, Arkansas, New York, Delaware, Nevada, Kentucky, Washington DC, Montana, Missouri, Colorado, Maryland, Tennessee, Oregon, Virginia, Iowa, Wisconsin, Louisiana, Georgia, Pennsylvania, North Dakota, Mississippi, South Dakota, Washington, Nebraska, Texas, Alaska, Puerto Rico, Idaho, Oregon, Maine, Vermont, West Virginia, Kansas.

    Quantity

    1488