Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
Description du dispositif
Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. || To be used for verifying the reportable range of tests on the Cholestech LDX System.
“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 - USA (nationwide) Puerto Rico and South Korea.
Description du dispositif
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 || Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.