BEUDAMED
    FDA Enforcement Class II Terminated

    Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.

    Recall: Z-0690-2013 · Reported January 23, 2013

    Enforcement

    Recall Number
    Z-0690-2013
    Event ID
    63771
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Perkinelmer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 23, 2013
    Initiation Date
    November 26, 2012
    Classification Date
    January 16, 2013
    Termination Date
    March 7, 2014
    Address
    940 Winter Street, N/A, Waltham, MA, 02451, United States

    Description

    Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.

    Reason

    Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

    Code Info

    Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175

    Distribution

    Nationwide Distribution.

    Quantity

    N/A