Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number: 80146501834 .. Hazard Class: III. Lots: attached list .. Lot lot affected: 2.555 units .. Number of units distributed: 1.980. 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.

According to company information: Ask your laboratory to take the Required Measures below to reduce the possibility of incidences of calibration errors. A. Once alternative batch is available, return any remaining stock from the following lots of ARCHITECT STAT High Sensitive Troponin-I reagents. (List not attached notice). B. If your laboratory DOES NOT have a batch of alternative reagent available in stock and has generated a valid calibration curve, immediately request the reagent batch replenishment. Continue to use these batches and follow the QC procedures recommended in the instructions for use. These lots have high potential for calibration failures with continued use. If calibration failures are repeated, they will prevent your lab from generating patient results. Once the replacement reagent lot is received, return any remaining stock from the reagent lots according to your laboratory procedures. C. If your laboratory has a batch of available alternate reagent in stock, continue to use these reagents immediately and begin using the alternate reagent batch. Return any remaining stock of batches of reagents according to your laboratory procedures. Your local Abbott representative can assist you in providing replacement products, financial credit and / or recommended alternative solutions. All future lots will have an appropriate shelf life before delivery. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link