Lactic Acid


  • 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

18 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: , Affected: 31497UN14, 09353UN15, 45216UN15, 14596UN15, 37055UN15, 14782UN16
  • Manufacturer
  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
  • Product Description
    ABX PENTRA Lactic Acid CP ref. A11A01721 || reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
  • Manufacturer
  • Model / Serial
    List Number (LN): 9D89-21 Lot Numbers: 31497UN14, 09353UN15, 45216UN15, 14596UN15, 37055UN15, 14782UN16
  • Product Description
  • Manufacturer
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