Events

Recall of Device Recall iSTAT CHEM 8 Cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Point Of Care Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58041
  • Event Risk Class
    Class 2
  • Event Number
    Z-2022-2011
  • Event Initiated Date
    2011-02-15
  • Event Date Posted
    2011-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98083
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrode, ion specific, sodium - Product Code JGS
  • Reason
    I-stat chem 8+ cartridge may generate false results for sodium, chloride and hematocrit.
  • Action
    The firm, Abbott Point of Care (APOC), sent an "Urgent Recall Notice" letter dated February 2011 with business reply cards attached via Fed Ex overnight to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of cartridges from the box numbers of identified lots; discontinue use as a precaution, if their cartridges are no longer traceable to a specific box; return all unused cartridges as instructed on the enclosed Business Reply Card; if they've provided another institution with the cartridges, provide the institution with a copy of this letter, and complete and return the business reply card to APOC. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-336-8020, Option 1 or your Abbott Point of Care representative.

Device

Device Recall iSTAT CHEM 8 Cartridge
  • Model / Serial
    510 K053110; Lot # C10247 boxes 0532 through 0593
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 || Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
  • Manufacturer
    Abbott Point Of Care Inc.

Manufacturer

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