Events

Recall of CHOLESTECH LDX ANALYZER

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
    59044
  • Event Risk Class
    III
  • Event Initiated Date
    2012-12-20
  • 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
    Alere has confirmed that these lots of controls may yield results which are out of range high for the level 2 control when tested with the alere cholestech ldx hdl test. please discontinue use of these lots and dispose of them in accordance with local regulations. alere cholestech ldx multianalyte control enables users to monitor the performance of total cholesterol (tc) high density lipoprotein (hdl) triglycerides (trg) glucose (glu) alanine aminotransferase (alt) and aspartate aminotransferase (ast) test procedures on the alere cholestech ldx system. if controls were within the ranges shown on the value assignment card that came with the control materials patient results should be considered clinically acceptable. alere has confirmed that patient samples continue to perform as expected.

Device

CHOLESTECH LDX ANALYZER
  • Model / Serial
    Model Catalog: 88769 (Lot serial: C2510A); Model Catalog: 88769 (Lot serial: C2510)
  • Product Description
    Alere Cholestech LDX Multianalyte Control 2 vial set
  • 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