Events

Avis De Sécurité sur Immunoassay Control

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 Randox.

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
  • Date
    2015-08-20
  • 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
    We are currently investigating an issue with the products listed below and are providing this urgent field safety notice to inform you of this occurrence. detail on affected devices: immunoassay control ia2640 lot 1364ec and immunoassay premium plus control ia3112 batch 334337 lot 1364ec. description of the problem: pth stability has been reduced in control lot 1364ec. it is now recommended that pth is tested immediately after reconstitution. risk to health: the contents of this letter should be discussed with your medical director. it is unlikely the error will cause misreporting of patient results as values for pth using this lot would fall outside of the assigned ranges. .

Device

Immunoassay Control
  • Modèle / numéro de série
    Immunoassay Control – IA2640 – 1364EC Immunoassay Premium Plus Control – IA3112 – 334337 –1364EC
  • Manufacturer
    Randox

Manufacturer

Randox