Events

Safety Alert for Alere Triage Rapid Diagnostic Test System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Alere San Diego.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-07-12
  • Event Date Posted
    2012-07-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120712a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: alere triage rapid diagnostic test system the united states food and drug administration (fda) has issued a class i recall concerning triage cardioprofiler panel (pn 97100cp), triage cardiac panel (pn 97000hs), triage profiler sob panel (pn 97300), triage bnp (pn 98000xr) and triage d-dimer (pn 98100), manufactured by alere san diego, inc.. identified lots, manufactured from 06/12/2011 to 04/08/2012 and distributed from 09/08/2011 to 06/05/2012, may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. certain lots affected have an increased frequency of troponin i results >0.05 ng/ml for samples which are found to be below 0.05 ng/ml upon additional testing. these false positive and false negative results are unpredictable within lots and may not be detected by quality control testing. there have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results. this product may cause serious adverse health consequences, including death. for details, please refer to fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm311387.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm311405.Htm. f you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 july 2012.

Device

Alere Triage Rapid Diagnostic Test System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Alere Triage Rapid Diagnostic Test System
  • Manufacturer
    Alere San Diego

Manufacturer

Alere San Diego
  • 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
    DH