LDL DIMENSION CHOLESTEROL CALIBRATOR - Lots 7HD066, 7KD027, 7LD012 and 8AD049. Registration number: 10321170610. 의 안전성 경고

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 company that owns the product registration in Brazil (Dade Behring Ltda.) Has already sent letters of information to all customers who received the aforementioned lots of the product in question. Anvisa's Technovigilance Unit is monitoring this case. #### Annex01: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_924_carta.pdf.