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
    SN2008(05)
  • Date
    2008-04-15
  • 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-cassette-pregnancy-test-kit&id=7199f825-9782-6eee-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
    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
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HPRA