Events

Recall of VIDAS NT PRO BNP 2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomerieux France Chemin De L'Or.

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
    73989
  • Event Risk Class
    Class 3
  • Event Number
    Z-2779-2016
  • Event Initiated Date
    2016-04-15
  • Event Date Posted
    2016-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145838
  • 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
    Due to a packaging error; the kit does not contain the correct number of c1 or c2 control vials.
  • Action
    bioMerieux. sent an Urgent Product Removal Notice letter dated April 26, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check for affected products in their inventory and discard the incomplete products. Customers were asked to complete the attached Acknowledgement Form and return it via fax to bioMerieux. For questions contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666.

Device

VIDAS NT PRO BNP 2
  • Model / Serial
    Reference number: 30449-01, Lot #1004474560.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV.
  • Product Description
    VIDAS NT-pro-BNP || Product Usage: || VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.
  • Manufacturer
    Biomerieux France Chemin De L'Or

Manufacturer

Biomerieux France Chemin De L'Or
  • Manufacturer Address
    Biomerieux France Chemin De L'Or, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA