Alerte De Sécurité sur One HbA1c FS - Registration no. 10350840195 - Models: R1: 2 x 15 ml / R2: 1 x 10 ml / R3: 1 x 5 ml - All lots in Brazil.

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.

DiaSys Diagnostics Systems GmbH, Germany, forwarded the notice to BioSys Ltd, which markets the One HbA1c FS product in Brazil, stating that one of its customers observed a falsely high HbA1c value of 10.4% in a sample analyzed with the DiaSys brand HbA1c IS reagent (photometric analysis). As this value was unlikely, the same sample was evaluated by the HPLC method, giving a value equal to 7.5%. The investigations, to find the cause of the falsely elevated value of HbA1c when tested by photometry, resulted in the diagnosis of Severe Monoclonal Gamopathy of the patient. Gammatids are known to cause nonspecific turbidity in patient samples due to protein precipitation, and therefore interfere with photometric analysis. These are very rare cases and can not be avoided most of the time. There are no reports in the Notivisa system. Anvisa follows this action.