Events

Recall of I-STAT SYSTEM - CREA 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
    26998
  • Event Risk Class
    II
  • Event Initiated Date
    2001-01-19
  • 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
    The cartridges manufactured to be incompatible with calibration factors stored in the instrument and measurements of blood samples read low by approx. 0.4 mg/dl at low end of the measurement range.

Device

I-STAT SYSTEM - CREA CARTRIDGE
  • Model / Serial
    Model Catalog: 06F10-02 (Lot serial: K00315 K00315A K00316); Model Catalog: 320100 (Lot serial: K00315 K00315A K00316); Model Catalog: 320100 (Lot serial: T00313 T00313A K00311); Model Catalog: 06F10-02 (Lot serial: T00313 T00313A K00311); Model Catalog: 06F10-01 (Lot serial: T00313 T00313A K00311); Model Catalog: 320100 (Lot serial: P00290 P00293 P00326); Model Catalog: 06F10-02 (Lot serial: P00290 P00293 P00326); Model Catalog: 06F10-01 (Lot serial: P00290 P00293 P00326); Model Catalog: 320100 (Lot serial: K00322B.); Model Catalog: 06F10-02 (Lot serial: K00322B.); Model Catalog: 06F10-01 (Lot serial: K00322B.); Model Catalog: 320100 (Lot serial: K00316A K00320 K00320A); Model Catalog: 06F10-02 (Lot serial: K00316A K00320 K00320A); Model Catalog: 06F10-01 (Lot serial: K00316A K00320 K00320A); Model Catalog: 06F10-01 (Lot serial: K00315 K00315A K00316)
  • Product Description
    I-STAT SYSTEM-CREA CARTRIDGE
  • 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