BEUDAMED
    FDA Recall Terminated

    NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.

    Recall: Z-0688-2013 · Initiated November 26, 2012

    Recall

    Recall Number
    Z-0688-2013
    Event Number
    63771
    Firm
    Perkinelmer
    FEI Number
    3006159931
    Product Code
    JLA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 26, 2012
    Posted
    January 16, 2013
    Terminated
    March 7, 2014
    Address
    940 Winter Street, Waltham, MA, 02451

    Description

    NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.

    Reason

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

    Action

    Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: - Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use. - If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing. - If a hole or crack is not visually detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation. Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2.

    Distribution

    Nationwide Distribution.

    Quantity

    3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)