Events

Safety Alert for Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters Determination Device ANVISA Registration Number: 0345161778; 10345161920 Hazard Class: II Affected Model: CS-2100i; CS-5100 Serial numbers affected: All serial numbers.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products GmbH..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2167
  • Date
    2017-02-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Clients using the INNOVANCE D-Dimer assay on the CS-Series blood coagulation analyzer (CS-2100i, CS-5100) should change the limit of the minimum extrapolation value within the INNOVANCE D-Dimer setting and the calibration must be according to the concentration of the calibrator to the new threshold.
  • Reason
    Siemens healthcare diagnostics has confirmed that in very rare circumstances a false negative result for the innovance d-dimer assay can be reported by cs-series automatic blood clotting analysis systems (cs-2100i, cs-5100) if the initial result is falsely flagged with an antigen excess error that triggers automatic re-reading at 1/19 dilution and the raw rerun signal is less than the method's white limit (lob). under such conditions, re-reading of low values ​​may be strongly affected by the signal noise of the optical system and may generate an erratically low optical gross value. this gross value will be corrected by the dilution factor and can be deduced from the calibration curve in a false low range.
  • Action
    Field Action Code PH 17-006 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make letter to the client.

Device

Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters De...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products GmbH.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA