BEUDAMED
    FDA Enforcement Class II Terminated

    HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120

    Recall: Z-0514-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0514-2014
    Event ID
    66894
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Laboratory Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    November 15, 2013
    Classification Date
    December 16, 2013
    Termination Date
    March 25, 2014
    Address
    180 Hartwell Road, N/A, Bedford, MA, 01730-2443, United States

    Description

    HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120

    Reason

    HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

    Code Info

    All lots

    Distribution

    Nationwide Distribution

    Quantity

    80319 Kits