ARCHITECT Anti-HBc II

  • Model / Serial
    Catalog Number: 8L44-25, 8L44-30, 8L44-35 Batch Number: 42072LI00 42072LI01 42253LI00 42253LI01 42255LI00 42255LI01 42256LI00
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
  • 1 Event

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
    MHSIDCCCDMIS

13 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: List Numbers: 8L44-25, 8L44-30, 8L44-35, Affected: Lot Numbers: 42072LI00, 42072LI01, 42253LI00, 42253LI01, 42255LI00, 42255LI01, 42256LI00
  • Manufacturer
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
  • Model / Serial
  • Manufacturer
  • Model / Serial
    List Number : 8L44-25 Lot Number : 42072LI00 Expiration Date 28-May-2015 List Number : 8L44-25 Lot Number : 42072LI01 Expiration Date : 28-May-2015 List Number : 8L44-25 Lot Number : 42253LI00 Expiration Date : 30-Jun-2015 List Number : 8L44-25 Lot Number : 42253LI01 Expiration Date : 30-Jun-2015 List Number : 8L44-30 Lot Number : 42255LI00 Expiration Date : 30-Jun-2015 List Number : 8L44-30 Lot Number : 42255LI01 Expiration Date : 30-Jun-2015 List Number : 8L44-35 Lot Number : 42256LI00 Expiration Date : 30-Jun-2015
  • Product Description
    IVD
  • Manufacturer
8 more