Device Recall Perkin Elmer NEOBASE NONDERIVATIZED MSMS KIT

  • Modèle / numéro de série
    Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    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.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Société-mère du fabricant (2017)
  • Source
    USFDA