Events

Avis De Sécurité sur Dimension® clinical chemistry system Dimension® Creatinine (CRE2) Flex® reagent cartridge

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 Limited .

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 that dimension® creatinine (cre2) assay exhibits a negative bias at the low end of the urine analytical measurement range (amr) (see table 2.). the limit of quantitation (loq) claim (5 mg/dl [442 µmol/l]) for urine samples is not met. siemens is actively investigating the root cause of the issue and is working to implement a solution. this issue also affects all future lots of cre2 until a solution is implemented. the serum/plasma cre2 amr is not affected by this issue. .

Device

Dimension® clinical chemistry system Dimension® Creatinine (CRE2) Flex® reagent cartridge

Manufacturer

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