BEUDAMED
    FDA Enforcement Class III Terminated

    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.

    Recall: Z-2096-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2096-2013
    Event ID
    65874
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Celera Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 12, 2013
    Classification Date
    August 26, 2013
    Termination Date
    October 1, 2013
    Address
    1401 Harbor Bay Pkwy, Alameda, CA, 94502-7070, United States

    Description

    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.

    Reason

    The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.

    Code Info

    Lot numbers: 10016853, 10017390, 10020343, 10021820 and 10022594. Expiry dates 12/5/2010, 06/15/2012, 09/08,2012, 08/13/2013 and 02/21/2014.

    Distribution

    USA Nationwide in the state of CA

    Quantity

    43 units