Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan.
Description du dispositif
AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20
“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.