ACETAMINOPHEN L3K

  • Model / Serial
    Model Catalog: 506-10 (Lot serial: 47662); Model Catalog: 506-10 (Lot serial: 47694); Model Catalog: 506-30 (Lot serial: 47694); Model Catalog: 506-10 (Lot serial: 48386); Model Catalog: 506-30 (Lot serial: 48385); Model Catalog: 506-10 (Lot serial: 48385); Model Catalog: 506-30 (Lot serial: 48253); Model Catalog: 506-10 (Lot serial: 48253); Model Catalog: 506-30 (Lot serial: 47663); Model Catalog: 506-10 (Lot serial: 47663); Model Catalog: 506-30 (Lot serial: 47662); Model Catalog: 506-30 (Lot serial: 48386); Model Catalog: 506-30 (Lot serial: 47650); Model Catalog: 506-10 (Lot serial: 47650); Model Catalog: 506-30 (Lot serial: 47649); Model Catalog: 506-10 (Lot serial: 47649); Model Catalog: 506-30 (Lot serial: 48294); Model Catalog: 506-10 (Lot serial: 48294); Model Catalog: 506-30 (Lot serial: 47695); Model Catalog: 506-10 (Lot serial: 47695)
  • Product Description
    ACETAMINOPHEN L3K
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • 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
    HC

14 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
  • Product Description
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic || Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml || Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml || In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
  • Manufacturer
  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide.
  • Product Description
    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
  • Manufacturer
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