BEUDAMED
    FDA Recall Terminated

    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

    Recall: Z-0687-2013 · Initiated November 26, 2012

    Recall

    Recall Number
    Z-0687-2013
    Event Number
    63771
    Firm
    Perkinelmer
    FEI Number
    3006159931
    Product Code
    NQL
    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

    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

    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

    819 kits (10 plates/kit)