Events

Avis De Sécurité sur VITROS® Immunodiagnostic Products Total β-hCG II Reagent Packs

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Ortho Clinical 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
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    As part of a field safety corrective action, ortho clinical diagnostics (ortho) has confirmed that when testing was conducted using the lots listed above, vitros® systems generated results within the measuring range for samples known to not contain measurable hcg. customers reported that their vitros® system reported results up to approximately 7.40 miu/ml (iu/l) for patient samples that should have been less than the measuring range of the assay (<2.39 miu/ml (iu/l)). our records indicate that you were shipped an affected lot of this product. .

Device

VITROS® Immunodiagnostic Products Total β-hCG II Reagent Packs
  • Modèle / numéro de série
    1410 (17-Jun-2016) 1420 (17-Jun-2016) 1430 (17-Jun-2016) 1440 (15-Aug-2016) 1450 (17-Aug-2016) 1460 (17-Aug-2016) 1470 (17-Aug-2016)
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics