Events

Field Safety Notices about SPOTCHEM ll Glucose, SPOTCHEM ll PANEL-1 and SPOTCHEM ll PANEL-V

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by ARKRAY Factory, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-01-28
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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.