Events

Recall of I-STAT SYSTEM - E3+ CARTRIDGE

According to Health Canada (via FOI), this recall involved a device in Canada 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
    79359
  • Event Risk Class
    II
  • Event Initiated Date
    2002-04-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Erroneously high hematocrit levels were generated using certain i-stat cartridges. a new version of software can detect electrical signals that give rise to erroneous reults.

Device

I-STAT SYSTEM - E3+ CARTRIDGE
  • Model / Serial
    Model Catalog: 06F08-02 (Lot serial: E02033); Model Catalog: 120500-02 (Lot serial: A01126); Model Catalog: 120500-02 (Lot serial: E02033); Model Catalog: 06F08-02 (Lot serial: E01337A); Model Catalog: 06F08-01 (Lot serial: E01337A); Model Catalog: 120500-02 (Lot serial: E01337A); Model Catalog: 06F08-02 (Lot serial: D02022); Model Catalog: 06F08-01 (Lot serial: D02022); Model Catalog: 120500-02 (Lot serial: D02022); Model Catalog: 06F08-02 (Lot serial: D01169); Model Catalog: 06F08-01 (Lot serial: D01169); Model Catalog: 120500-02 (Lot serial: D01169); Model Catalog: 06F08-02 (Lot serial: A01243); Model Catalog: 06F08-01 (Lot serial: A01243); Model Catalog: 120500-02 (Lot serial: A01243); Model Catalog: 06F08-02 (Lot serial: A01126); Model Catalog: 06F08-01 (Lot serial: A01126); Model Catalog: 06F08-01 (Lot serial: E02033); Model Catalog: 06F06-02 (Lot serial: E01307); Model Catalog: 06F06-01 (Lot serial: E01307); Model Catalog: 123000-02 (Lot serial: E01307); Model Catalog: 06F06-02 (Lot serial: E01308); M
  • Product Description
    I-STAT CARTRIDGE E3+
  • Manufacturer
    ABBOTT POINT OF CARE INC.

Manufacturer

ABBOTT POINT OF CARE INC.
  • Manufacturer Address
    ABBOTT PARK
  • 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
    HC