Events

Recall of Device Recall Cardiac Marker Test

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
    67910
  • Event Risk Class
    Class 2
  • Event Number
    Z-1540-2014
  • Event Initiated Date
    2014-03-20
  • Event Date Posted
    2014-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126592
  • 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
    These lots may not recover within range when tested using certain commercially available controls.
  • Action
    Alere San Diego, Inc. initiated this recall by sending out notification letters via email and/or regular mail on March 20, 2014. The letter titled "URGENT MEDICAL DEVICE CORRECTION", dated "March 20, 2014, informed customers of the reason for recall, and potential impact, product description with lots numbers, customer/distributor required action, and contact information. The letter was accompanied by a "Customer/Distributor Verification Form". Customers were instructed that they may continue to use reagent lots 329599 and 331265. " If they are using an alternate commercial control with Reagent Pack Lots 329599 or 331265, they can receive the Alere Triage¿ BNP QC Controls PN 98201 by requesting them on the Verification Form. "Customers were instructed to share this information with their laboratory staff, including their laboratorys medical director and retain this notification as part of their laboratory Quality System documentation. For questions regarding this recall call 858-805-2000, ext 3015. " If they have forwarded the product listed above to another laboratory, please provide a copy of this letter to them. " Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice. Only one Verification Form is required per facility. Customers with questions were instructed to call 877-308-8287 or email Triage.Support@alere.com.

Device

Device Recall Cardiac Marker Test
  • Model / Serial
    Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS).  Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
  • Product Description
    Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.
  • 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