“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.
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 || a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Worldwide, including USA, Puerto Rico, and Canada.
Description du dispositif
Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. || Product No. 61100KVC || 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide || 10 plastic pipettes || Wampole Laboratories || Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.