Events

Safety Alert for QUIKLYTE DILUTION TESTER, Model 1x50mL; registration: 10345161157, risk class: I - products that present minimal risk to the user. Serial / Lot Number: 4MD707.

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 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
    1559
  • Date
    2015-03-26
  • 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 company, the health risk is related to a potential correction of up to 5% in the sodium parameter, which may generate a lower result than expected
  • Reason
    Presence of positive bias, possibly above 5%, which may result in unnecessary fault or correction in dilution check. dilution check failure prevents the complete installation of the quiklyte integrated multisensor.
  • Action
    According to the registry holder, customers were advised of the following recommendations: • Discontinue use and discard the product from the batch involved. • Review the letter with the laboratory officer. • Review inventory / inventory of this product to determine replacement requirements. • Complete Field Action Effectiveness Check Form. It was not recommended to review the results previously generated by the laboratory.

Device

QUIKLYTE DILUTION TESTER, Model 1x50mL; registration: 10345161157, risk class: I - products that ...

Manufacturer

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