Events

Recall of Device Recall DiaSorin Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diasorin 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
    30931
  • Event Risk Class
    Class 3
  • Event Number
    Z-0703-05
  • Event Initiated Date
    2004-05-20
  • Event Date Posted
    2005-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36845
  • 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
    Device, Microtiter Diluting/Dispensing - Product Code JTC
  • Reason
    When software was updated for the washer program of the bio tek automated microplate washer model elx50, the software did not automatically clear old versions of the wash program when new ones were added.
  • Action
    Customers were notified by phone and informed of the problem and recommended users to use only the newer wash program which is identified is a 'W' in front of the program.

Device

Device Recall DiaSorin Software
  • Model / Serial
    version 7
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, FL, NH, PA, SD, TX, WA
  • Product Description
    Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    USFDA