Events

Recall of Device Recall Alere Cholestech LDX hsCRP Test Cassette,

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
    64701
  • Event Risk Class
    Class 2
  • Event Number
    Z-1178-2013
  • Event Initiated Date
    2013-03-06
  • Event Date Posted
    2013-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116831
  • 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
    C-reactive protein, antigen, antiserum, and control - Product Code DCK
  • Reason
    The alere cholestech ldx¿ hscrp cassette (pn 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hscrp compared to a reference method or repeat testing on the same patient sample.
  • Action
    Alere sent an Urgent Medical Device Recall letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to block all stock of the affected lot in their warehouses; discontinue use and discard all stock on hand, complete the provided Customer Verification form to document disposal, contact their primary consignees and advise them of the required discontinuation and disposal of the affected lot. For question call 877-308-8289.

Device

Device Recall Alere Cholestech LDX hsCRP Test Cassette,
  • Model / Serial
    Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. || Product Usage: || Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Manufacturer Address
    Alere San Diego, Inc., 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