Events

Recall of Device Recall NucliSens EasyQ Enterovirus serotype 68 ref.200300 v1.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by bioMerieux, 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
    58792
  • Event Risk Class
    Class 2
  • Event Number
    Z-2740-2011
  • Event Initiated Date
    2011-05-10
  • Event Date Posted
    2011-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100303
  • 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
    Real Time Nucleic Acid Amplification System - Product Code OOI
  • Reason
    The nuclisens easyq enterovirus reagents are unable to detect enterovirus serotype 68, in respiratory samples.
  • Action
    BioMerieux Vitek, Inc. sent an "Urgent Product Correction Notice" letter on/about May 10, 2011. The letter included; a description of the product, problem, possible impact to the patient and recommendations. Recommendations included instructing customers to discontinue the use of the kit for the detection of Enterovirus 68 and Rhinovirus 87 serotypes and noted the corrected IFU will be available the first week of April 2011. An Acknowledgement form was attached to be returned via fax. For additional questions please contact your local BioMerieux Clinical Customer representative at (800) 682-2666, option 3, option 2.

Device

Device Recall NucliSens EasyQ Enterovirus serotype 68 ref.200300 v1.1
  • Model / Serial
    Catalog number: 200300, Lot number: 10042001, 9081001, 9112403, 9030902 and 9030901.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA
  • Product Description
    NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 || In Vitro Diagnostic Test
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA