Events

Recall of Device Recall iSTAT CREA Cartridge Blood Gas Panel

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
    55178
  • Event Risk Class
    Class 2
  • Event Number
    Z-0456-2011
  • Event Initiated Date
    2010-03-17
  • Event Date Posted
    2010-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90226
  • 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 based, enzymatic, creatinine - Product Code CGL
  • Reason
    The i-stat crea cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
  • Action
    Abbott Point of Care issued Urgent Product Recall Notification letters dated March 2010 to all direct customers identifying the affected product and the actions to be taken. Customers were instructed to determine if they had cartirdges that had been stored above 25 degrees Celsius, and if so, contact Abbott for replacement or credit. Abbott Technical Support can be contacted at 800-366-8020 option 1 about this recall.

Device

Device Recall iSTAT CREA Cartridge Blood Gas Panel
  • Model / Serial
    Lot numbers A09279A and A09280A, Exp March 2010
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throughout USA and Canada.
  • Product Description
    i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
  • 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