Events

Recall of Device Recall iSTAT PT/INR 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
    55895
  • Event Risk Class
    Class 2
  • Event Number
    Z-1996-2010
  • Event Initiated Date
    2010-05-05
  • Event Date Posted
    2010-07-13
  • 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=92194
  • 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
    A high mean bias (12-16%) was documented in 8 lots of i-stat pt/inr cartridges. this may lead a clinician to believe that a patient is adequately anticoagulated when they are not. inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. no reports of injury have been received.
  • Action
    Urgent recall notifications were sent on May 13 2010. Customers were instructed to discontinue use and to return the identified lots. Additional questions are directed to Abbott Point of Care Technical Support at 800-366¿8020, Option 1 or your Abbott Point of Care representative.

Device

Device Recall iSTAT PT/INR Cartridge
  • Model / Serial
    Catalog numbers: 04J50-01, 04J50-02. Lot numbers: N09315, exp 4/28/2010; N09323, exp 5/14/2010; N09323A, exp 5/14/2010; N09346A, exp 5/28/2010; S09347, exp 5/28/2010; S09354, exp 6/14/2010; T10009, exp 6/28/2010; T10011, exp 6/28/2010.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: Argentina, Hong Kong, China, Finland, Greece, India, Portugal, Russian Federation, Saudi Arabia, United Arab Emirates, Italy, Spain, Australia, Germany, UK, Sweden, The Netherlands, France, Canada.
  • Product Description
    i-STAT PT/INR Cartridge || Abbott Point of Care, 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