Events

Safety Alert for Trade name: ALDOLASE RANDOX. Technical Name: ALDOLASE. ANVISA registration number: 80158990141. Risk class: I - Low Risk. Model Affected: AD189. Batch / serial numbers affected: 370813; 365747; 347842; 347842; 339868; 339868; 330802; 322815

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by RANDOX BRASIL LTDA; RANDOX LABORATORIES LTD.

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
    2011
  • Date
    2016-10-31
  • 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
    Update the reagent installation with the correct settings using the data provided by the manufacturer. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Caution: This problem causes the customer who specifically uses the RX device to fail (RX4900 REGISTER no. 80158990104) unable to perform the calibration.
  • Reason
    The aldolase specific application protocol for the imola rx equipment is incorrect. the settings do not allow absorbance change, and calibration is not possible with incorrect settings.
  • Action
    Field Action Code 7f06.0001 triggered under the responsibility of the company RANDOX BRASIL LTDA. Company is announcing Aldolase specific application protocol for Rola Imola equipment.

Device

Trade name: ALDOLASE RANDOX. Technical Name: ALDOLASE. ANVISA registration number: 80158990141. R...

Manufacturer

RANDOX BRASIL LTDA; RANDOX LABORATORIES LTD