BEUDAMED
    FDA Enforcement Class II Terminated

    Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.

    Recall: Z-1662-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1662-2015
    Event ID
    71022
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2015
    Initiation Date
    March 5, 2015
    Classification Date
    May 23, 2015
    Termination Date
    January 16, 2018
    Address
    62 Flanders-Bartley Rd, Flanders, NJ, 07836-4715, United States

    Description

    Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.

    Reason

    The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

    Code Info

    Water Feed Kit - Product Code/Catalog #'s 10288216 and 10389714

    Distribution

    Worldwide Distribution.

    Quantity

    8 bottles