Events

Safety Alert for Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distributed as follows in Brazil: 17 in São José dos Pinhais-PR; 16 in Rio de Janeiro-RJ; 3 in Campinas-SP; 2 in Recife-PE.

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 Inc..

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
    1838
  • Date
    2016-03-10
  • 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
  • Reason
    Siemens healthcare comes through letter dc 16-01 to alert its customers in brazil about the siro reagent, lot eb6064 that does not meet the stability of open bottle of 2 days. internal tests showed a bias (bias) ranging from -82% to + 123% in a pool sample with a concentration of sirolimus of 8.7 ng / ml [9.5 mmol / l] when tested on subsequent days after well within two days. shortly after opening, the results are not affected at the beginning of the stability period.
  • Action
    The field action code 16-01 initiated by Siemens addresses the sending of a Letter to the Customer with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences) . Recommendation to Users and Patients: Siemens recommends discontinuing use and disposing of the Sirolimus reagent stock from lot EB6064. In addition, it is recommended that the laboratory conduct a retrospective analysis of the results of Sirolimus samples generated using the EB6064 reagent batch. However, it is worth noting that the sample collection and handling section contained in the Sirolimus reagent's instructions for sample stability is consulted in order to decide whether these samples can be retested using an alternative batch of reagent.

Device

Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distri...

Manufacturer

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