Events

Safety Alert for Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; 251626; 290672W; 161762. /// Product 2. BCS XP SYSTEM, registry 10345161642, risk class I, batches affected: 311502; 280727; 280800; 301266; 301267; 280775; 221651; 331848; 442036.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; 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
    1595
  • Date
    2015-05-21
  • 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
    According to the manufacturer the health risk is related to the possibility of inappropriate classification, for higher values, of Factor IX, for results of patients in the lower reading range. It is important to know that hemophilia B is characterized by the deficiency of Factor IX coagulation activity that results in prolongation of bleeding after injury, dental extractions or surgeries, and recurrent delay or bleeding before complete wound healing.
  • Reason
    Release of erroneously high results for factor ix with the application protocols of the bcs and bcs xp systems at the lower limit of the measurement range.
  • Action
    The registry holder will change protocols for the implementation of the Factor IX Define test. In addition, it is advised to discontinue use of the "Factor IX with Pathromtin SL [34]" application protocol and instead use the "Factor IX with Pathromtin SL [463]" application protocol; discontinue the use of extrapolation for reading values ​​at lower levels of the "Factor IX with Pathromtin SL [463]" application protocol and "Factor IX with Actin [467]" application protocol. Do not report patient results below 30% F IX for application protocols "Factor IX with Actin FSL [471]".

Device

Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; ...

Manufacturer

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