Events

Avis De Sécurité sur SPOTCHEM ll Glucose, SPOTCHEM ll PANEL-1 and SPOTCHEM ll PANEL-V

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 ARKRAY Factory, 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
  • Date
    2016-01-28
  • 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
    It was found that a lower reading may be given for the glucose item when the blood glucose concentration of a sample exceeds approximately 350mg/dl. more specifically, when the blood glucose concentrafion exceeds the upper limit of the measurement range (450mg/dl), the message ”over”, indicating that the reading is outside the measurement range, was not displayed and readings of approximately 300~400mgldl may be given. in addition, when within the measurement range, for high glucose concentrations (approximately 350~450mgldl), there is a possibility that the reading may be around -20% of the known concentration. .

Device

SPOTCHEM ll Glucose, SPOTCHEM ll PANEL-1 and SPOTCHEM ll PANEL-V
  • Modèle / numéro de série
    SPOTCHEM ll Glucose (IVD) (Code77160) Lot: EA5H87,EA5G86,EA5F84,EA5E83,EA5D82,EA5B80,EA5A79 SPOTCHEM ll PANEL-1 (IVD) (Code 77184) Lot : QCSJ49,QC5H48,QC5G47,QC5F46,QC5E45,QC5D44,QC5C43,QCSB42,QC5A41 SPOTCHEM ll PANEL-V (IVD) (Code 77189) Lot : PL5J03,PL5H02,PL5601,PL5F99,PL5E98,PL5D97,PL5C95,PL5894,PL5A93
  • Manufacturer
    ARKRAY Factory, Inc.

Manufacturer

ARKRAY Factory, Inc.