BEUDAMED
    FDA Enforcement Class II Terminated

    Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441

    Recall: Z-1706-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1706-2020
    Event ID
    85203
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 22, 2020
    Initiation Date
    March 16, 2020
    Classification Date
    April 14, 2020
    Termination Date
    March 26, 2021
    Address
    7335 Executive Way, Frederick, MD, 21704-8354, United States

    Description

    Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441

    Reason

    Extended Expiration Date prior to clearance

    Code Info

    Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002 UDI: (01)10190302015103

    Distribution

    US Nationwide distribution.

    Quantity

    35 units