Devices

Device Recall Architect Free T4 MasterCheck

  • Model / Serial
    lots 82130M, Exp 06/30/2008; 82140M, Exp 10/31/2008; and 82150M, Exp 12/31/2008
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including state of Puerto Rico and country of Canada.
  • Product Description
    Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. || Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. || Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories
  • 1 Event

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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