Device Recall Triage Drugs of Abuse Plus TCA 25 Test Kit

  • Modelo / Serial
    Lots 403111, 406741, 396588, 398577, 396587
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - United States Nationwide and the countries of Japan, Canada
  • Descripción del producto
    Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of || Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. || Product Usage: || The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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