Events

Recall of Software specific to microtiter plate instrument for use with Diastat AntiBeta2 Glycoprotein 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
    30924
  • Event Risk Class
    Class 3
  • Event Number
    Z-0674-05
  • Event Initiated Date
    2004-10-26
  • 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=36812
  • 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
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) - Product Code MSV
  • Reason
    Data reduction program written for specific sutomated microtiter plate insturment (bio-tek elx800 reader) is faulty in that the positive result limit is to be greater than 15 u/ml, rather than greater than or equal to 15 u/ml.
  • Action
    Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.

Device

Software specific to microtiter plate instrument for use with Diastat AntiBeta2 Glycoprotein kit
  • Model / Serial
    software version 12
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CT, MI, MT, UT & CANADA
  • Product Description
    Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay 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