Events

Recall of Device Recall Abbott Point of Care iStat cTnI 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 Canada Limited.

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
    64043
  • Event Risk Class
    Class 2
  • Event Number
    Z-0716-2013
  • Event Initiated Date
    2012-11-01
  • Event Date Posted
    2013-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115267
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • Reason
    Apoc has determined that 10 boxes of i-stat ctni cartridges from lot p12179 have an incorrect barcode applied to the cartridge portion pack.
  • Action
    APOC sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Abbott Point Of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point Of Care representative for questions regarding this information.

Device

Device Recall Abbott Point of Care iStat cTnI cartridge
  • Model / Serial
    List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Abbott Point of Care i-Stat cTnI cartridge. || The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
  • Manufacturer
    Abbott Point of Care Canada Limited

Manufacturer

Abbott Point of Care Canada Limited
  • Manufacturer Address
    Abbott Point of Care Canada Limited, 185 Corkstown Road, Nepean Canada
  • 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