Device Recall Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM

  • Modèle / numéro de série
    Lot Numbers: 617341, 619236
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM || MASS SPECTROMETRY KIT || Product Number: 3026-0030. || This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
  • Manufacturer
  • 1 Event

Fabricant

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