Events

Avis De Sécurité sur Clinitest® hCG Cassette Pregnancy Test Kit

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Siemens Healthcare Diagnostics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2011(33)
  • Date
    2011-12-19
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/clinitest-hcg&id=5580f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HPRA