BEUDAMED
    FDA Enforcement Class II Terminated

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    Recall: Z-1267-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1267-2014
    Event ID
    67599
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AMS Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 2, 2014
    Initiation Date
    February 11, 2014
    Classification Date
    March 21, 2014
    Termination Date
    September 29, 2016
    Address
    1790 N Commerce Pkwy, N/A, Weston, FL, 33326-3204, United States

    Description

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    Reason

    Marketing the devices outside 510(k) requirements

    Code Info

    Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.

    Distribution

    Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.

    Quantity

    167 kits