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
    SN2011(33)
  • Date
    2011-12-19
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/clinitest-hcg&id=5580f825-9782-6eee-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
    Lots 028619, 028924, 029997, 030240, 030431, 030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924, 032106 and 032180 of the clinitest hcg pregnancy test kits have been recalled by the manufacturer due to the potential for borderline or false positive results with commercially available controls and patient samples.
  • Action
    ACTION OR RECOMMENDATIONS FOR HEALTHCARE PROFESSIONALS  • Ensure that all relevant staff in your institution are informed of this  recall  • Determine if you have lots 028619, 028924, 029997, 030240, 030431,  030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924,  032106, and 032180 of the above product  • Locate and cease using product from the lots listed above  • Determine how much of this product has been used  • Follow the distributor / manufacturers recommendations for quarantine  and disposal of product  • Follow up with patients as required.  ACTION OR RECOMMENDATIONS FOR PATIENTS  • Patients who have had a recent pregnancy test administered by a healthcare  professional but are concerned that the positive 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