Events

Recall of Nichols Advantage ACTH Test System, catalog number 62-7004.

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
    32042
  • Event Risk Class
    Class 2
  • Event Number
    Z-1044-05
  • Event Initiated Date
    2005-04-22
  • Event Date Posted
    2005-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39001
  • 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
    Radioimmunoassay, Acth - Product Code CKG
  • Reason
    Performance does not meet claims in the directional insert concerning correlation with the irma acth assay.
  • Action
    Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.

Device

Nichols Advantage ACTH Test System, catalog number 62-7004.

Manufacturer

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