Nationwide and to the following foreign countries: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, Australia
Descripción del producto
AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore
Descripción del producto
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.
Descripción del producto
The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.
Descripción del producto
The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
“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.
“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.