Events

Recall of Bio-Intact PTH (1-84) Assay

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
    31730
  • Event Risk Class
    Class 2
  • Event Number
    Z-0810-05
  • Event Initiated Date
    2005-04-07
  • Event Date Posted
    2005-05-10
  • 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=38404
  • 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, Parathyroid Hormone - Product Code CEW
  • Reason
    Values do not agree with directional instructions.
  • Action
    Firm sent separate notices for each lot of product to customers dated March 25, 2005 requesting destruction of remaining product and affirmation of that activity via a response form. Users were also provided detailed listing of performance characteristics related to the deficiencies for thier information and evaluation per thier own lab''s SOP''s.

Device

Bio-Intact PTH (1-84) Assay

Manufacturer

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