“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.
Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Description du dispositif
Alere INRatio PT/INR Test Strips, Alere INRatio || PT/INR System Professional || - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 || - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 || The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. || In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Description du dispositif
INRatio Monitors || - 0100004 Alere INRatio PT/INR System Professional || - 0100007 INRatio Prothrombin Time (PT) Monitoring System || - 0100137 Alere INRatio Replacement Monitor || The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. || In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Description du dispositif
INRatio 2 Monitors || - 0200431 Alere INRatio 2 PT/INR Professional Testing System || - 0200432 Alere INRatio 2 PT/INR Home Monitoring System || - 0200433 Alere INRatio 2 PT/INR Home Monitoring System || - 0200457 Alere INRatio 2 Replacement Monitor || - 55112 Alere INRatio 2 Replacement Monitor || - 55131 Alere INRatio 2 Replacement Monitor || - 55128A Alere INRatio 2 PT/INR Professional Monitoring System || The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. || Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. || Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L || 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.
“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.
“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.
“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.