Events

Safety Alert for Trade Name: Lysercell Technical Name: Lysing Solution For Hematology ANVISA Registration Number: 80015490091 Hazard Class: I Affected Model: Lysercell WDF Affected Lot: P5002.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Sysmex do Brasil Indústria e Comércio LTDA..

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
    2001
  • Date
    2016-08-12
  • 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, customers who purchased this batch of product were contacted via email and possible telephone connection, which explained about the destruction of purchased lots, which consists of complete de-characterization of the product for health; besides the reimbursement of the products. Customers were informed that the use of the product did not interfere with the quality and quantity of the diagnostic tests, and that such a product disposal request situation applies because of the legitimacy of the sysmex encrypted seal; in addition to avoiding the difficulty of using a new unit with the same code. letter of communication with the attached client recommendations. 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 lysercell-wdf product is an in vitro diagnostic reagent used in cell counting instruments. the reagent has in its label an encrypted code, which is a mechanism that acts against falsifications. the batch p5002 has a print replication of the encrypted codes and, if the exchange is performed by a new reagent unit with the replicate code (same batch p5002), this exchange will not be identified by the instrument. failure to print does not influence the final product quality or diagnostic test.
  • Action
    Field Action Nº RC0105 triggered under the responsibility of Sysmex do Brasil Indústria e Comércio LTDA. Classification of the field action: Product disuse for health

Device

Trade Name: Lysercell Technical Name: Lysing Solution For Hematology ANVISA Registration Number: ...

Manufacturer

Sysmex do Brasil Indústria e Comércio LTDA.