Events

Avis De Sécurité sur Hemoglobin A1c_3 (A1c_3 and A1c_3M) Reagent Lots

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 Siemens Healthcare Diagnostics Inc..

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
    Siemens healthcare diagnostics has confirmed the hemoglobin a1c_3/ a1c_3m reagent kit lots listed in table 1 used on the advia® 1200, 1650, 1800, 2400, and xpt chemistry systems may demonstrate an increased occurrence of high %hba1c bias. siemens internal investigation demonstrates reagent lots 230 and 231 may exhibit a positive bias averaging 0.6% hba1c units, ranging from -0.1% to 1.1% hba1c units. the bias was observed when comparing %hba1c means to ngsp pooled patient target-value assigned samples ranging from approximately 5.5% to 8.0% hba1c. the maximum bias was observed at higher %hba1c concentrations. qc samples may exhibit a similar bias. .

Device

Hemoglobin A1c_3 (A1c_3 and A1c_3M) Reagent Lots
  • Modèle / numéro de série
    Lot Number Hemoglobin A1c_3 (160 test kit) A1c_3, A1c_3M 10379673 10379673 230 Hemoglobin A1c (800 test kit) A1c_3, A1c_3M 10485591 10485591 230 Hemoglobin A1c (800 test kit) A1c_3, A1c_3M 10485591 10485591 231
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    AMPMDRS