Events

Field Safety Notices about Clearview HCG Pregnancy Test Kit

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Unipath Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2007(02)
  • Date
    2007-06-12
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/clearview-hcg-pregnancy-test-kit&id=e099f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Lot hg0050 of the clearview hcg pregnancy test kit (cat number 500158) has been recalled by the manufacturer due to the potential for false negative results i.E. a negative result obtained in pregnancy.
  • Action
    Action or Recommendations for Healthcare Professionals Ensure that all relevant staff in your institution are informed of this recall   Determine if you have lot number HG0050 of the above product Locate and cease using product from lot number HG0050   Determine how much of this product has been used   Follow the distributor / manufacturer recommendations for quarantine and disposal of product Follow up patients as required Action or Recommendations for Patients Patients who have had a recent pregnancy test in hospital but are concerned that the negative result received may be incorrect should contact or seek a retest from their GP, family planning clinic or pharmacist.

Device

Clearview HCG Pregnancy Test Kit
  • Model / Serial
  • Product Description
    Clearview HCG Pregnancy Test Kit
  • Manufacturer
    Unipath Limited

Manufacturer

Unipath Limited
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HPRA