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
    31228
  • Event Risk Class
    Class 3
  • Event Number
    Z-0638-05
  • Event Initiated Date
    2005-02-14
  • Event Date Posted
    2005-03-18
  • 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=37417
  • 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, Vitamin D - Product Code MRG
  • Reason
    An internal inspection indicates that calibrator 2 and conjugate are switched in their positions in the integral. this will result in calibrator 1 rlu's similar to that of background rlu, and calibrator 2 rlu's near expected range. a curve can not be calculated from this data.
  • Action
    DiaSorin Customer Notification dated 02/14/05 was sent to customers instructing them to destroy all kits from the affected lot number. Customers were also asked to complete and return a form indicating how many kits were destroyed.

Device

Device Recall Liaison 25OH Vitamin D Kit
  • Model / Serial
    manufacturer part # 310900, Lot #114668
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA, Spain, Germany & Belgium
  • Product Description
    Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
  • 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