ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
Modèle / numéro de série
List Number (LN): 8L44-10, lot 54570LI00.
Description du dispositif
IMMUNOANALYSIS CHIMIOLUMINISCENTE DE MICROPARTICULAS (CMIA) FOR THE QUALITATIVE DETECTION OF ANTIBODIES AGAINST THE ANTIGENOCORE OF HEPATITIS B VIRUS (ANTI HBC) HUMAN PLASMA AND PLASMA, INCLUDING POST-MORTEM RENEWED SAMPLES (WITHOUT CARDIAC TREATMENT).
“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.