Events

Field Safety Notices about Dimension® clinical chemistry system Dimension® Creatinine (CRE2) Flex® reagent cartridge

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 Siemens Healthcare Diagnostics Limited .

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
  • 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
    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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS