Events

Recall of Device Recall DiaSorin

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
    39413
  • Event Risk Class
    Class 3
  • Event Number
    Z-1237-2007
  • Event Initiated Date
    2007-08-21
  • Event Date Posted
    2007-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55433
  • 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
    in vitro diagnostic - Product Code MRG
  • Reason
    25 hydroxyvitamin d ria kits may contain the incorrect lot of tracer.
  • Action
    Consignees were notified by phone on 8/21/07 followed by a written notification by Fax or email. The letter described the product and problem and recommended to inspect the kits and to destroy all tracer vials of lot number 726023. They also requested the consignee to return the findings by fax or mail.

Device

Device Recall DiaSorin
  • Model / Serial
    Part # 68100E, lot # 119604A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.
  • Product Description
    25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, P.O Box 285, Stillwater MN 55082-7536
  • Source
    USFDA