Events

Recall of Electronic Data Interchange

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
    53483
  • Event Risk Class
    Class 2
  • Event Number
    Z-0865-2010
  • Event Date Posted
    2010-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85597
  • 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
    Calculator/data processing module for clinical use - Product Code JQP
  • Reason
    Abbott point of care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the cds test record only.
  • Action
    Urgent Recall Notification letters were sent by Fed Ex to all US customers on September 29, 2009 and worldwide on October 1, 2009. Questions should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.

Device

Electronic Data Interchange
  • Model / Serial
    i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
  • Product Description
    i-STAT HL7 Interface || The HL7 Interface product is an accessory to the analyzer
  • 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