Devices

Device Recall iSTAT G3 Cartridge

  • Model / Serial
    Lot P08321C, Abbott List number 06F03-01 (USA and Canada), Abbott List Number (rest of world) 06F03-02; Box numbers 1491 and 1534.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.
  • Product Description
    i-STAT G3+ Cartridge; || pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. || Abbott Point of Care Inc., || Abbott Park, IL 60064 || The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon dioxide, and pH.
  • Manufacturer
    Abbott Point of Care Inc.
  • 1 Event

Manufacturer

Abbott Point of Care Inc.
  • Manufacturer Address
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • 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
    USFDA

One device with a similar name

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Device Recall iSTAT G3 Cartridge
  • Model / Serial
    List number 03P78-25 :Lot number N13183
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Product Description
    i-STAT G3+ Cartridge || pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
  • Manufacturer
    Abbott Point Of Care Inc.