Events

Recall of Device Recall 25OH Vitamin D

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nichols Institute Diagnostics.

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
    29504
  • Event Risk Class
    Class 2
  • Event Number
    Z-1118-04
  • Event Initiated Date
    2004-06-30
  • Event Date Posted
    2005-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33920
  • 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
    Lower than expected results are obtained.
  • Action
    Firm sent Customer Bulletin No 04-09-AD on June 30, 2004. It addresses the issues and advises customers as to alternative actions, including appending results with a caution statement regarding low recovery.

Device

Device Recall 25OH Vitamin D
  • Model / Serial
    Not limited to specific lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France.
  • Product Description
    Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
  • Manufacturer
    Nichols Institute Diagnostics

Manufacturer

Nichols Institute Diagnostics
  • Manufacturer Address
    Nichols Institute Diagnostics, 1311 Calle Batido, San Clemente CA 92673-6316
  • Source
    USFDA