Abbott Diagnostics International, Ltd.

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Description

  • Manufacturer Address
    Abbott Diagnostics International, Ltd., Carr # 2 Km 58.0, Cruce Davila, Barceloneta PR 00617
  • 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
  • 1 Event

One device in the database

  • Model / Serial
    Lot # 76175Q100 exp. date 4/18/10; Lot # 79412Q100 exp. date 7/22/10; Lot # 82584Q100 exp. date 10/20/10.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including Puerto Rico.
  • Product Description
    ARCHITECT HAVAB-M Reagent || A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.