iSTAT Level 2 Control

  • Model / Serial
    Abbott List Number: 06F13-01; Lot number B09342 - CLEW A20 artwork 726778-01A.pdf; Lot number B09154 - CLEW A20 artwork 726774-01A.pdf; Lot number B09342 - CLEW A18 artwork 726668-01A.pdf. Expiration: 11/2010. Abbott List Number: 025715, CLEW A20 Compact Disc containing value assignment sheets.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruquay, and Yemen.
  • Product Description
    i-STAT Level 2 Control Value Assignment Sheets || Human Consumption
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Abbott Point of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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