Trade name: CELL-DYN Emerald Cleaner / CELL-DYN Emerald Cleaner; ANVISA registration number: 80146501650; lots: 6901 and 6953; quantity of the affected lot: 104 units (distributed as follows: 41 in São Paulo-SP, 12 in Ouro Preto do Oeste-RO, 16 in Rio de Janeiro-RJ, 16 in Duque de Caxias-RJ, 7 in Brasília-DF ; 12 in Rio Branco-AC).

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
  • Source
    ANVSANVISA