Events

Avis De Sécurité sur LIFECODES HLA-DQA1/B1 Typing Kit

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 Immucor.

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
    2015-12-30
  • 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 investigating a single instance of false positive reactivity of probe dqb253 associated with an allele pair of dqb1*03:03:02:01, dqb1*03:04:01. a false positive result causes the exclusion of dqb1*03:03:02:01/ 03:04:01 as a possible allele combination. the risk to the patient is considered low due to the low frequency of this event, and the additional risk reduction achieved through application of the requirements and limitations described in the product insert. results from these kits are not to be used as the sole basis upon which a clinical decision affecting the patient is made. due to the complex nature of hla typing, qualified personnel should review data interpretation and typing assignments, as per the limitations of the procedure section of the product insert. .

Device

LIFECODES HLA-DQA1/B1 Typing Kit
  • Modèle / numéro de série
  • Manufacturer
    Immucor

Manufacturer

Immucor
  • Société-mère du fabricant (2017)
    Grifols Sa
  • Source
    AMPMDRS