Events

Recall of ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN CARD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALERE CANADA.

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
    42037
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-06
  • 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
    There is an error in the french translation of the alere binaxnowr legionella urinary antigen card instructions for use revisions 4 and 5. the negative result portion of the result interpretation section in these incorrect revisions states: "a negative specimen will give a single pink-to-purple colored control line in the top half of the window indicating a presumptive negative result. this control line means that the detection part of the test was not done correctly but l. pneumophila serogroup 1 antigen was detected." this is an incorrect statement. the translation should read: "a negative specimen will give a single pink-to-purple colored control line in the top half of the window indicating a presumptive negative result. this control line means that the detection part of the test was done correctly but no l. pneumophila serogroup 1 antigen was detected.".

Device

ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN CARD
  • Model / Serial
    Model Catalog: 852-012 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 852-000 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    Alere BinaxNOWr Legionella Urinary Antigen Card
  • Manufacturer
    ALERE CANADA

Manufacturer

ALERE CANADA
  • Manufacturer Address
    OTTAWA
  • 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