CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL / TG, TRIGGS, TRIG / GB, CHOL / CHOL2, HDL-C plus 3rd generation / HDLC3, LDL_C plus 2nd generation / LDL_C. UA2 / UA plus - See Annex I (products and records). Potential customers affected - Annex II 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 manufacturer received a total of 6 complaints related to inadequately reduced test results based on Trinder's reaction to Acetaminophen and Metamizole. The frequency of occurrence is very remote, as the interference situation occurs only in certain rare circumstances, when there is insufficient waiting time between the administration of these drugs and collection of blood for the tests. The probability of occurrence of a Trinder test interference also depends on the frequency of use of the following medications: Paracetamol (acetaminophen), Metamizol (Novaminsulfone, dipyrone). Acetaminophen and Metamizole are two of the most commonly used analgesics. For both drugs relevant plasma concentrations leading to interferences are achieved directly following intravenous administration, during intravenous administration, or as a result of metabolic disturbances or drug abuse. Critical concentrations of acetaminophen occur due to accidental intoxication as well as intended to commit suicide.