Device Recall Triage Drugs of Abuse Panel

  • Modèle / numéro de série
    Lot/Unit Codes: 186625
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and country of Canada.
  • Description du dispositif
    Triage Drugs of Abuse Panel, Model Number: 95000. || Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biosite Inc, 9975 Summers Ridge Rd, San Diego CA 92121
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Lots 235991 and 238928.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and to Canada.
  • Description du dispositif
    Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 || An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.
  • Manufacturer