Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Assay

  • Modèle / numéro de série
    Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
  • Description du dispositif
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic || Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml || Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml || In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sekisui Diagnostics P.E.I. Inc., 70 Watts Ave, Charlottetown Canada
  • Société-mère du fabricant (2017)
  • Source
    USFDA