Events

Recall of iSTAT Analyzer FUSO Analyzer 300F

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
    56832
  • Event Risk Class
    Class 2
  • Event Number
    Z-0594-2011
  • Event Initiated Date
    2010-09-20
  • Event Date Posted
    2010-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94600
  • 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 measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Reason
    I-stat analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
  • Action
    Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed. Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action. Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.

Device

iSTAT Analyzer FUSO Analyzer 300F
  • Model / Serial
    Product number: 310003, all lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Kong, India, Ireland, Israel, Japan, Kingdom of Saudi Arabia, Korea, Kuwait, Mauritius, Mexico, Nigeria, Norway, Panama, Paraguay, Peoples Republic of China, Peru, Poland, Portugal, Qatar, Russia, Singapore, South Africa, Spain, Sweden, UK, Sultanate of Oman, Switzerland, Taiwan, R.O.C., Thailand, Turkey, UAE, Uruguay, and Yemen.
  • Product Description
    FUSO Analyzer 300F || Abbott Point of Care, Princeton, NJ 08540 || Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
  • 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