Events

Safety Alert for Data-Cyte Plus Day 0.8% Technical Name: ANTIBODIES / SYSTEMS FOR DIFFERENTIAL CELL COUNTING ANVISA Registration Number: 80134860207 Hazard Class: III Model Affected: Code 213627 Serial Numbers Affected: 611316015

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

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
    2061
  • Date
    2017-01-27
  • 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
    Discontinue use of the product and send / return affected panels to destruction. 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
    Through in-house tests, data-cyte plus day # 12 cell day 0.8%, lot: 611316015, validity 28-01-2017 has been identified that can react falsely positive with serum / plasma samples containing no unexpected antibodies. preliminary results from the internal investigation have shown that false positive results may be due to blood reagent cells or a combination of blood reagent cells and dg gel card. the equipment was excluded as a contributing factor because manual tests without the equipment confirmed the observations. the risk analysis has shown that there is no harm to the patient and that the remaining risk is exclusively reduced to a delay in transfusion but in no case can result in a wrong transfusion due to the interpretation of the test.
  • Action
    Field Action Code 2017-01 triggered under the responsibility of the company Grifols Brasil Ltda. Company will collect for further destruction of the product.

Device

Data-Cyte Plus Day 0.8% Technical Name: ANTIBODIES / SYSTEMS FOR DIFFERENTIAL CELL COUNTING ANVIS...

Manufacturer

Medion Diagnostics Grifols
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Source
    ANVSANVISA