Events

Recall of Device Recall ISTAT PT/INR cartridges

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
    62536
  • Event Risk Class
    Class 2
  • Event Number
    Z-2157-2012
  • Event Initiated Date
    2012-03-01
  • Event Date Posted
    2012-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110873
  • 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
    Test, time, prothrombin - Product Code GJS
  • Reason
    The i-stat pt/inr cartridges have the potential to exhibit incorrectly elevated results.
  • Action
    Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.

Device

Device Recall ISTAT PT/INR cartridges
  • Model / Serial
    List number 04J50-01 04J5O-02 03P89-24  Lots begininng with R11 or R12
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- (USA) nationwide
  • Product Description
    I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA || This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
  • 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