Recall of Alere Cholestech LDX Calibration Verification

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

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
    63918
  • Event Risk Class
    Class 3
  • Event Number
    Z-0747-2013
  • Event Initiated Date
    2012-10-22
  • Event Date Posted
    2013-01-29
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-09-26
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    Out of range (increased) hdl cholesterol results.
  • Action
    A recall letter was sent on 10/22/12 to all customers who purchased the Alere Cholestech LDX Mutianalyte Control, 2 vial set, Catalog Number 88769, Lot #C2510 & Lot #C2510A. The letter informed the customers 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. Customers are instructed of the actions to be taken. On 11/16/12, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog 88770, Lot#271097. The problem identified is that these lots of calibration verification materials may yield results which are out of range high when tested with the Alere Cholestech LDX HDL test. Customers are instruted of the actions to be taken. On 3/6/13, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 Vial set, Catalog # 88770, Lot#298148 and 301886. The recall expanded to include the Alere Cholestech LDX Multianalyte Control, 2 vial Set, Catalog # 88769, Lots#C2572, C2572A, C2593 and C2593A. Customers are instructed to complete and fax the enclosed verification form within 10 days. Customers with questions are instructed to contact Alere San Diego, 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8289, fax (858) 805-8457, and responses.ts@alere.com.

Device

  • Model / Serial
    Lot#271097, 298148, and 301886
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
  • Product Description
    Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 || Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Manufacturer Parent Company (2017)
  • 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