Events

Recall of Cholestech LDX High Sensitivity CReactive Protein (hsCRP) Test Cassette

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

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
    49142
  • Event Risk Class
    Class 3
  • Event Number
    Z-2457-2008
  • Event Initiated Date
    2006-08-09
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72854
  • 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
    Vanilmandelic acid test system. - Product Code DCK
  • Reason
    Test results are high, outside of control material upper limit specification. results could be as high as 15%.
  • Action
    Cholestech provided its three distributors a notification letter/response form with instructions to distribute the letter to their customers/end users dated August 9, 2006. The letter instructed customers to discontinue use of the lot of cassettes, return remaining cassettes to Cholestech through the Technical Service Representative and to complete and return the response form. The end users returned the signed letters directly to Cholestech so that effectiveness checks could be completed.

Device

Cholestech LDX High Sensitivity CReactive Protein (hsCRP) Test Cassette
  • Model / Serial
    Catalog #12-807, Lot #C17-6434
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Virginia, Texas and North Carolina, Ohio, Arkansas, Washington, Florida , California and Michigan.
  • Product Description
    Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.
  • Manufacturer
    Cholestech Corp

Manufacturer

Cholestech Corp
  • Manufacturer Address
    Cholestech Corp, 3347 Investment Blvd, Hayward CA 94545-3808
  • 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