Pak Lx Assay

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    HSAHSA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: , Affected: Lot # 3003658 and 3004022
  • Manufacturer
  • Model / Serial
  • Product Description
    In-vitro diagnostics - haematological, histological and cytological products
  • Manufacturer
  • Model / Serial
    Batch Number: 3003658 3004022
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
  • Model / Serial
    Pak Lx AssayProduct Code: GT-PLXLot Number: 3003658with Conjugate Lot: 3003881Lot Number: 3004022with Conjugate Lot: 3003881ARTG Number: 217307
  • Manufacturer