Safety Alert for # Trade Name: IMUNO-LATEX FR / REUMATOIDE FACTOR # COD. 2860-L / 28100-L # Technical Name: RHEUMATOID FACTOR # Registration: 10310030071 # Risk Class: II - Products presenting medium risk to the user or patient and low risk to public health # Presentation: Kit for 60 or 100 tests # Latex Suspension: Latex suspension coated with human IgG stabilized in glycine buffer Positive Control Serum: Human serum in saline buffer and sodium azide Control Negative Serum: Human serum in saline buffer and sodium azide

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, "a false reactive result for RF would lead to a misdiagnosis that the patient has anti-FR antibodies, but as described in the instructions for use, the kit is a test aid in the diagnosis of nonspecific inflammation with rapid onset (1 - 2 weeks) Positive results should always be confirmed by other diagnostic and clinical methods of the patient Another situation presented is agglutination of the reagent even before mixing with the patient sample, making it impossible to determine a Therefore, there are no health risks, since positive results must be complemented and the reagent will often present agglutination even before mixing with the sample, making it impossible for the laboratory to perform the test procedure.