Events

Recall of Device Recall DiaSorin ETIANA Screen Kit, 96 Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories 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
    55293
  • Event Risk Class
    Class 2
  • Event Number
    Z-1478-2011
  • Event Initiated Date
    2010-03-01
  • Event Date Posted
    2011-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90492
  • 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
    in vitro diagnostic - Product Code LKJ
  • Reason
    Inaccurate results-- consumer complaints of increased positivity rates with the ana screening kit.
  • Action
    Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.

Device

Device Recall DiaSorin ETIANA Screen Kit, 96 Test
  • Model / Serial
    Model number N0093, manufacture dates 09/17/2009 and 10/12/2009, lot numbers 24592003and 24592035.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.
  • Product Description
    DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA