Events

Recall of Cholestech GDX A1C Test Cartridge

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
    49359
  • Event Risk Class
    Class 2
  • Event Number
    Z-2460-2008
  • Event Initiated Date
    2006-08-03
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73203
  • 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
    Cartridge - Product Code LCP
  • Reason
    Cholestech corp. was notified by the foreign manufacturer of the a1c test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.
  • Action
    A customer notification letter was sent to Cholestech consignees who had received product from this lot. The letter dated 8/3/2006 instructed customers to discontinue use of the lot of product, destroy product according to in-house standard procedures and contact Cholestech Technical Services for replacement. It also instructed to provide a copy of the letter to other users if the lot of product was further distributed. A response form was included with instructions to complete and return. Contact Cholestech Corp at 1-510-781-3505 for assistance.

Device

Cholestech GDX A1C Test Cartridge
  • Model / Serial
    Catalog #12-658, Lot #066T28
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
  • Product Description
    Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).
  • 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