Events

Recall of Device Recall Euro Diagnostica DIASTAT ANA (antinuclear antibody)

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

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
    77107
  • Event Risk Class
    Class 2
  • Event Number
    Z-0306-2018
  • Event Initiated Date
    2017-02-14
  • Event Date Posted
    2017-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154980
  • 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
    Antinuclear antibody, antigen, control - Product Code LKJ
  • Reason
    Euro diagnostica has identified a deviation in one of the components of the diastat ana (fana200), lot ts 2076. the kit might not perform correctly and so potentially yield false positive samples.
  • Action
    Consignees were notified by phone or email beginning 2/15/2017. The Urgent Field Safety Notice identified affected product, described the issue, and stated affected product should be destroyed. A response form was asked to be returned. Questions can be directed to Malin Bornschein at malin.bornschein@eurodiagnostica.com

Device

Device Recall Euro Diagnostica DIASTAT ANA (antinuclear antibody)
  • Model / Serial
    Lot: TS 2076
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN, NE, TX
  • Product Description
    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA || DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
  • Manufacturer
    Euro Diagnostica AB

Manufacturer

Euro Diagnostica AB
  • Manufacturer Address
    Euro Diagnostica AB, Box 50117, Lundavagen 151, Malmo Sweden
  • Manufacturer Parent Company (2017)
    C&P Investors Limited
  • Source
    USFDA