Events

Field Safety Notices about Clinitest® hCG Cassette Pregnancy Test Kit

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

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
    SN2008(05)
  • Date
    2008-04-15
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/clinitest-hcg-cassette-pregnancy-test-kit&id=7199f825-9782-6eee-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 97552 and lot 97574 of the clinitest hcg pregnancy test kits 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 97552 and lot 97574 of the above product Locate and cease using product from lot 97552 and lot 97574 Determine how much of this product has been used Follow the distributor / manufacturers 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

Clinitest® hCG Cassette Pregnancy Test Kit

Manufacturer

Siemens Healthcare Diagnostics