Alerte De Sécurité sur IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR RUBELLA IgM - registration 80145901047. Lots 0740 and 0751. See Annex 1 - Distribution List

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 manufacturer informs to assist in the diagnosis of a recent or acute Rubella infection, the IgM test result is usually used in conjunction with patient signs and symptoms as well as a history of potential exposure to Rubella. Independent literature (eg Center for Disease Control Surveillance of Vaccine-Preventable Disease) generally suggests performing a second blood collection 5-10 days later for re-testing of both IgM and IgG Rubeola and / or alternative test method to confirm the infection of Rubeóla to patient with initial IgM positive results. To date, there are no customer complaints reported to the OCD indicating damages to patients who are associated with the affected lots. This event may not be detectable quickly unless the employee observes higher-than-expected results with quality control samples. There may be an increase in the number of patient samples that are on the limit or reactive line compared to the normal distribution of your laboratory and may also indicate that your lot is affected. In addition, there may be an increase in the mean S / C value for negative patient samples at your facility