Events

Safety Alert for Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116

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
    1682
  • Date
    2015-09-01
  • 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
    Siemens confirmed for TTPa: variation greater than 3 seconds in the normal range and / or greater than 15% in the pathological range with the product at validity. It is possible that samples with values ​​close to the medical decision point may present deviations in the ranges: normal up to 4 seconds and pathological up to 33%. The upward trend of aPTT in most cases will be recognized by controls outside the designated range.
  • Reason
    Siemens healthcare diagnostics has confirmed internally that for lot 557116 the values ​​of the controls may be outside the designated ranges. in addition, it was observed that the results of the normal control presented values ​​with a tendency of high. this indicates change of product performance even within the validity.
  • Action
    The company advises you to discontinue use and also discard any and all remaining material from the above-mentioned batch of Dade Actin Activated Cephaloplastin Reagent. This field action has the same content as the action communicated through alert 1569; the company's quality department identified the same problem in this lot, which generated this new field action.

Device

Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116

Manufacturer

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