Alerta De Seguridad para Trade Name: Lysercell Technical Name: Lysing Solution For Hematology ANVISA Registration Number: 80015490091 Hazard Class: I Affected Model: Lysercell WDF Affected Lot: P5002.

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.

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