Events

Recall of Nichols IRMA Intact PTH Assay, catalog No. 40-2171

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
    31493
  • Event Risk Class
    Class 2
  • Event Number
    Z-0809-05
  • Event Initiated Date
    2005-03-25
  • 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=37984
  • 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
    Firm noted a change in performance and therefore changed the labeled performance specifications in the directional insert portion of the labeling.
  • Action
    Firm sent customer notifications to firms on March 9 and 11, 2005 which were deemed not appropriate upon review by the FDA, firm agreed to resend notices approved by FDA on March 25, 2005 which requested that customers cease using the lots and destroy inventory for credit.

Device

Nichols IRMA Intact PTH Assay, catalog No. 40-2171
  • Model / Serial
    Lots 40-504553/4 released March 4, 2005 and kit lots 40-501687/8 released March 18, 2005
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel
  • Product Description
    Nichols IRMA Intact PTH Assay, catalog No. 40-2171
  • Manufacturer
    Nichols Institute Diagnostics

Manufacturer

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