Alerta De Seguridad para LYSERCELL Technical Name: LISE SOLUTION FOR HEMATOLOGY ANVISA Registration Number: 80015490091 Hazard Class: I Affected Model: LYSERCELL WDF - 5L Serial Numbers Affected: P6006 - SINGLE LOT WITH THE ABOVE PROBLEM

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.

THE CUSTOMERS WHO PURCHASED THIS PRODUCT LOT WERE CONTACTED THROUGH E-MAIL AND POSSIBLE TELEPHONE CONNECTION, WHICH EXPLAINED THE USE OF THE LOTS ACQUIRED, WHICH CONSISTS OF THE COMPLETE DISCARACTERIZATION OF THE HEALTH PRODUCT; BEYOND REFUND OF PRODUCTS. THE CLIENTS WERE INFORMED THAT THE USE OF THE PRODUCT DOES NOT INTERFERE IN THE QUALITY AND QUANTITY OF THE DIAGNOSTIC TESTS, AND THAT SUCH STATUS OF DISPOSAL OF PRODUCTS APPLIES FOR PRIMAR FOR THE LEGITIMACY OF THE SYMPTOM CRYPTOGRAPHY SEAL; IN ADDITION TO AVOIDING THE DIFFICULTY OF USING THE NEW UNIT WITH THE SAME CODE. LETTER OF COMMUNICATION WITH THE RECOMMENDATIONS TO THE CUSTOMER IN ANNEX.