Events

Recall of Device Recall Alere Cholestech LDX System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alere San Diego.

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
    60391
  • Event Risk Class
    Class 2
  • Event Number
    Z-0964-2012
  • Event Initiated Date
    2010-11-16
  • Event Date Posted
    2012-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105233
  • 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
    in vitro diagnostic - Product Code CHH
  • Reason
    Alere has identified that a bias on results for certain analytes tested on the alere cholestech ldx system may exist due to humidity variability.
  • Action
    Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verification form. A previous notice from Alere sent in November 2010 instructs users to contact Alere to receive the ROM pack upgrade. Customers may email LDXROM@alere.com to request an electronic form to complete and return via email. Customers can expect their ROM packs approximately 10 to 14 business days after Alere receives their request. If customers have transferred ownership to another party, they can email Alere at LDXROM@alere.com with the updated contact information. If customers are not currently using their Cholestech LDX System, it is recommended that the ROM Pack upgrade be installed prior to restarting use of any Cholestech LDX analyzer. Customers with questions regarding this communication can call Alere at (877) 441-7440, option 1 or email at LDXROM@alere.com.

Device

Device Recall Alere Cholestech LDX System
  • Model / Serial
    ROM versions prior to 3.40
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including USA
  • Product Description
    Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
  • Manufacturer
    Alere San Diego

Manufacturer

Alere San Diego
  • Manufacturer Address
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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