Events

Recall of Device Recall VIDAS Estradiol II (E2 II)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioMerieux SA.

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
    76727
  • Event Risk Class
    Class 2
  • Event Number
    Z-1801-2017
  • Event Initiated Date
    2017-03-17
  • Event Date Posted
    2017-03-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154042
  • 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
    Radioimmunoassay, estradiol - Product Code CHP
  • Reason
    Fulvestrant cross reacts with the vidas estradiol ii immunoassay and may cause falsely elevated estradiol results in patients treated with fulvestrant.
  • Action
    bioMerieux sent an Important Product Safety Notice A Product Safety Notice to all affected customers on March accounts on March 17, 2017, informing them not to use VIDAS Estradiol II test to test estradiol level in patients under Fulvestrant therapy. The letter did not request return of any of the product, and requested that they return an acknowledgement form acknowledging receipt of the notice and that they have followed the instructions and implemented the actions in the field notice. Customers with questions were instructed to contact their bioMerieux Customers Service representative. For questions regarding this recall call 314-731-8805.

Device

Device Recall VIDAS Estradiol II (E2 II)
  • Model / Serial
    Lots 1005081700, 1005172850 & 1005359170
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
  • Product Description
    VIDAS Estradiol II, Ref 30431-01, 60 tests || The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
  • Manufacturer
    BioMerieux SA

Manufacturer

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