“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.
Alere Cholestech LDX ALT-AST Cassette (An in vitro medical device (IVD) used for the quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in whole blood)Catalogue Number: CT12-788Lot Number: 297313AARTG Number: 160951
Alere Cholestech LDX hsCRP Cassette (An in vitro medical device (IVD) used in the quantitative determination of C-reactive protein in whole blood or serum )Catalogue Number: CT12-807Lot Numbers: 274632 & 281847/14ARTG Number: 160951
Alere Cholestech LDX Multianalyte Control (An in vitro diagnostic medical device used to monitor the performance of total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System)Catalogue Number: CT88769Lot Numbers: C2572, C2572A, C2593 & C2593AARTG Number: 160951
epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), An in vitro diagnostic medical device (IVD).Catalogue Number: CT-1004-00-00Lot Numbers: 07-12289-00 & 07-01263-00ARTG Number: 198588
“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.