BEUDAMED
    FDA Enforcement Class II Terminated

    Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443

    Recall: Z-1705-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1705-2020
    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 Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443

    Reason

    Extended Expiration Date prior to clearance

    Code Info

    Lot Codes: S119_2174739 S119_2108428 P119_2149305 N119_2078114 S218_2069395 V118_1991154 T118_1990946 S118_1988603 P118_1996940 S117_1988306 UDI: (01)10190302006064

    Distribution

    US Nationwide distribution.

    Quantity

    66 units