Events

Recall of Device Recall GCX Mountable DownloaderRecharger;

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
    56560
  • Event Risk Class
    Class 3
  • Event Number
    Z-2462-2010
  • Event Initiated Date
    2010-08-20
  • Event Date Posted
    2010-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94075
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Reason
    Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
  • Action
    Abbott Point of Care, Inc. sent Urgent Recall Notices, dated August 20, 2010, by Federal Express to two Clarion Health locations. The letter identified the product, the issue, and the actions to be taken by the firm and the customers. 1) An Abbott Point of Care representative will contact the customers to plan the replacement of affected product at their facility. 2) Replacement will occur in batches of approximately 50 units at a time. 3) Abbott will provide personnel to perform the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice.. If you have any questions regarding this information please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.

Device

Device Recall GCX Mountable DownloaderRecharger;
  • Model / Serial
    List number: 06F23-57/514005, part number 016060-01.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - USA, including the state of Indiana
  • Product Description
    GCX Mountable Downloader-Recharger; || (accessory to the i-STAT Portable Clinical Analyzer (model 300). || The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.
  • 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