Events

Recall of Device Recall UCG BetaSlide Monoclonal II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inverness Medical Professional 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
    54745
  • Event Risk Class
    Class 3
  • Event Number
    Z-2501-2010
  • Event Initiated Date
    2010-02-12
  • Event Date Posted
    2010-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89150
  • 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
    Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
  • Reason
    Specific lots no longer meet their stated limit of detection claims of 2000 miu/ml for the ucg-slide test and 500 miu/ml for the ucg-beta slide monoclonal ii test.
  • Action
    The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.

Device

Device Recall UCG BetaSlide Monoclonal II
  • Model / Serial
    Code number 16B4; lot numbers 0224099, Exp. 7/9/2010; 0618299, Exp 10/30/2010; 0818039, Exp. 1/11/2011 and 1010168, Exp. 3/20/2010.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and to Australia
  • Product Description
    UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.
  • Manufacturer
    Inverness Medical Professional Diagnostics

Manufacturer

Inverness Medical Professional Diagnostics
  • Manufacturer Address
    Inverness Medical Professional Diagnostics, 2 Research Way, Princeton NJ 08540-6628
  • Source
    USFDA