Events

Recall of Device Recall LIAISON 25OH Vitamin D 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
    46832
  • Event Risk Class
    Class 3
  • Event Number
    Z-1240-2008
  • Event Initiated Date
    2008-02-01
  • Event Date Posted
    2008-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68312
  • 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
    Vitamin D test systems - Product Code MRG
  • Reason
    Inaccurate measurements: kits may sporadically recover kit and external control values out of range high.
  • Action
    Consignees were notified by a Diasorn Customer Notification Letter sent by email on 2/1/08. The letter instructs users to stop using the affected kits, destroy any kits remaining in inventory and to return a response form in order to receive replacement product. For additional information contact 1-800-328-1482.

Device

Device Recall LIAISON 25OH Vitamin D Kit
  • Model / Serial
    Lot Numbers: 120422 and 120423.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA states of AR, CA, GA, IA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OR, PA, TN, UT and WA and country of Austria.
  • Product Description
    LIAISON¿ 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, P.O Box 285, Stillwater MN 55082-0285
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    USFDA