Events

Recall of Diastat Software for use with Diastat AntiMitochondrial Antibody Kit

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
    30922
  • Event Risk Class
    Class 3
  • Event Number
    Z-0673-05
  • Event Initiated Date
    2004-04-12
  • Event Date Posted
    2005-04-06
  • 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=36810
  • 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
    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DBM
  • Reason
    The data reduction program written for a specific automated microtiter plate instrument (bio-tek elx800 reader) was found to be faulty. this program is used to calculate the cut off values for diastat anti-mitochondrial antibody kit. program should include a borderline specification to indicate repeat testing is needed.
  • Action
    A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.

Device

Diastat Software for use with Diastat AntiMitochondrial Antibody Kit
  • Model / Serial
    Software version 12
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CT, KS, MA & WA
  • Product Description
    Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody 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