Alerta De Seguridad para AxSYM Troponin-I Reagents, Anvisa Record nº 10055310760 List numbers 3C29-15 and 3C29-20, all batches.

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 revised quality control procedure for low control is as follows: Analyze a single sample of a low control No abbott once every four hours. The control should have a manufacturer-reported mean of less than 2.0 ng / mL (ug / L) when tested with the AxSym Troponin-I Reagent Assay. If you can not test a non-abbott low control, use a sample. The concentration of this sample should be representative of its patient population; i.e., the target should be <0.3 ng / mL (ug / L). If the concentration of this healthy sample changes out of the normal range (> 0.5 ng / mL (ug / L) recalibration is required. For additional information call Customer Service Center 0800 11 90 99.