Events

Recall of Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

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
    33412
  • Event Risk Class
    Class 2
  • Event Number
    Z-0007-06
  • Event Initiated Date
    2005-08-31
  • Event Date Posted
    2005-10-06
  • 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=41850
  • 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, Human Chorionic Gonadotropin - Product Code DHA
  • Reason
    Data from internal testing indicates that the nichols advantage invasive trophoblast antigen assay cartridges (ita)(lot no 62-500261) and hyperglycosylated human chorionic gonadotropin assay cartridges (h-hcg)(lot no 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
  • Action
    Withdrawal letter was sent 08/30/2005 which request customers to stop using the product immediately and discard any remaining materials. A response card was included.

Device

Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

Manufacturer

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