“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.
The product was shipped nationwide to 28 Wholesalers, 15 retail pharmacies and pharmacy chains, 18 managed markets/Mail order facilities, and 616 health care professionals. There are 29 Canadian consignees.
Description du dispositif
The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. || US Market BD Blood Glucose Monitoring System kit catalog Numbers: || 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); || 322050 (BD Latitude Diabetes Management System); || 322051 (BD Logic Blood Glucose Monitor); || 32205175 ( BD Logic Blood Glucose Monitor); || 322200 (Paradigm Link Blood Glucose Monitor - clear); || 322201 ( Paradigm Link Blood Glucose Monitor - smoke); || 322202 (Paradigm Link Blood Glucose Monitor - blue); || 322203 (Paradigm Link Blood Glucose Monitor - purple). || Canadian market BD Blood Glucose Monitoring System kit catalog numbers: || 322000 (BD Latitude Diabetes Management System); || 322001 (BD Logic Blood Glucose Monitor).