Events

Recall of DiaSorin programming 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
    30929
  • Event Risk Class
    Class 3
  • Event Number
    Z-0702-05
  • Event Initiated Date
    2004-04-12
  • 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=36821
  • 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
    Enzyme Immunoassay, Tracrolimus - Product Code MLM
  • Reason
    The software program written for use in the automated microtiter plate reader (bio-tek elx800) for use with the pro-trac ii tacrolimus elisa kit was found to be faulty. assay software program did not include the calibrator zero od specification (stdo>=1.500) as specified in the product insert.
  • Action
    Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.

Device

DiaSorin programming software
  • Model / Serial
    version 12
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, Washington DC, FL, KY & Canada
  • Product Description
    Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit
  • 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