Events

Safety Alert for Trade name: Tubes for collection of vacuum blood. Technical name: BOTTLE OR MATERIAL FOR COLLECTION, STORAGE OR TRANSPORT OF BIOLOGICAL SAMPLES. ANVISA registration number: 80502070045. Hazard class: I. Model affected: TUBO OLEN K50-305M. Serial numbers affected: 4666

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Mobius Life Science Industra e Comercio de Produtos para Laboratorios LTDA.; PLAST LAB S.A.R.L..

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
    2325
  • Date
    2017-06-13
  • 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
    The problem will not have direct influence on the patient. As for the user (clinical analysis laboratories) it is recommended to exchange the defective products of lot 4666 with any other available in our company. 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
  • Reason
    The k50-305m vacuum collection tube had technical complaints from customers that even centrifuging at the rate primarily indicated by the supplier did not effectively separate the gel which compromised the analysis and its result. in view of the safety of our users and our commitment to quality, we immediately block this batch of our inventory. all tests applicable to validate this information are being carried out internally and, once confirmed the problem, we will take the appropriate measures.
  • Action
    Field Action Code 2266 launched under the responsibility of the company Mobius Life Science Industra e Comercio de Produtos para Laboratorios LTDA Company will update, correct or supplement the instructions for use.

Device

Trade name: Tubes for collection of vacuum blood. Technical name: BOTTLE OR MATERIAL FOR COLLECTI...

Manufacturer

Mobius Life Science Industra e Comercio de Produtos para Laboratorios LTDA.; PLAST LAB S.A.R.L.
  • Source
    ANVSANVISA