Events

Recall of Device Recall Alere Triage BNP Calibrators For the Beckman Coulter Access Family of Immunoassay Systems

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
    68469
  • Event Risk Class
    Class 3
  • Event Number
    Z-1928-2014
  • Event Initiated Date
    2014-05-30
  • Event Date Posted
    2014-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127976
  • 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
    Test,natriuretic peptide - Product Code NBC
  • Reason
    Alere san diego is recalling alere triage bnp calibrators for the beckman coulter access family of immunoassay systems because the bottle labeled as calibrator level 5 actually contains calibrator level 4. this results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected level 5 calibrator.
  • Action
    Alere sent an Urgent Medical Device Recall letter dated May 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The primary consignees were instructed to block all stock of the affected lot in their warehouses; discontinue use and return all stock on hand, complete the provided verification form to document receipt of the notice and quantity to be returned, contact their primary consignees and advise them of the required discontinuation and return of the affected lot. For customers (or their sub-distributors) who have inventory on hand, Alere San Diego, Inc. will provide replacement product to the customer for the quantity of units that they must return. Customers are instructed to complete the attached reply form with the amount of unused product that will be returned for replacement. Customers with questions are instructed to contact Alere San Diego at 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8287, triage.support@alere.com

Device

Device Recall Alere Triage BNP Calibrators For the Beckman Coulter Access Family of Immunoassay ...
  • Model / Serial
    Lot #328163
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide and the countries of Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
  • Product Description
    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 || The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ¿ as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ¿ as an aid in the assessment of severity of congestive heart failure ¿ for the risk stratification of patients with acute coronary syndromes ¿ for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.
  • 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