Device Recall Architect Sirolimus Reagent Pack

  • Model / Serial
    Lot 80162M100, Expiry Date May 03, 2011
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.
  • Product Description
    Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25. || The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy.
  • Manufacturer
  • 1 Event

Manufacturer

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