Safety Alert for ADVIA Centaur HCY (HOMOCYSTEIN) - Record # 10345160332

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.

Dilution of the patient sample mainly serves to resolve results above the calibration range for hyperhomocytokineemic patients. Severe hyperhomocysteinemia may occur due to marked deficiencies of B-complex vitamins, or it may be associated with chronic renal failure. Rarely, severe hyperhomocysteinemia and hyperhomocysteinemia occur due to hereditary genetic defects such as cystathionine beta-synthase deficiency. Homocysteine ​​is used as an adjunct assay with direct measurement of specific B-complex vitamins or genetic test. In these cases, a negative bias in the dilution recovery result would have no impact on future treatment or mask a high value. As determination of homocysteine ​​levels is used as an aid in the diagnosis of a B-complex deficiency or hereditary deficiency, and treatment is based on the conditions of folic acid and vitamin B12 or genetic testing, it is not necessary to review the results of the samples that have previously been diluted 1:10, nor is it necessary to repeat the dilution tests of these patients. Thus, based on the research carried out, it was determined that there is no risk to health. Using a dilution of 1 to 10, a laboratory can achieve recovery from 60 to 70%, which will not impact the treatment options and will not mask a high value. Treatment is based on folic acid and vitamin B12 values ​​and / or genetic testing. Homocysteine ​​is typically an incidental finding and not a primary issue in diagnosis, so there is no risk to health.