Events

Safety Alert for SIMPLASTIN EXCEL S - Lots: 161580,161581,161661,161662,161639,161664,161716,161503,161506,161554,161582 and 161640

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMÉRIEUX - BRASIL.

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
    687
  • Date
    2003-02-12
  • 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
    Check if there are any batches in your stock. If any, please contact BIOMÉRIEUX BRASIL S / A, by telephone 21 2444.1483 - Technical Assistance to Reagents, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes. According to the company's statement, the termination of this payment is scheduled until August 26, 2003.
  • Reason
    Prolonged results in coagulation times. there is variation of the measured levels of vacuum remaining in the lyophilized vials. this vacuum failure was identified as the cause of the randomly altered clotting times in those batches. according to this information, the presence of atmospheric air along with an active principle would be the cause of the bad performance, observed in certain batches.
  • Action
    The company informs that a number of Corrective Actions have been implemented for both the Simplastin Excel S product lines and Simplastin Excel. These are: Vacuum control, bottle to bottle, more stringent, improvement of the bottle closure system in the production process and revision of the technical procedure sheets: In the instructions for use a check of the reconstitution of the freeze-dried tablets by the customer, as well as performing a double quality control test before using the vial for testing. Collection of products manufactured in the period from February 2000 to November 2002.

Device

SIMPLASTIN EXCEL S - Lots: 161580,161581,161661,161662,161639,161664,161716,161503,161506,161554,...

Manufacturer

BIOMÉRIEUX - BRASIL
  • Source
    ANVSANVISA