Alerta De Seguridad para Calibrator Immunodiagnosis Vitros for 25-OH Vitamin D Total, Record no. 80145901419, lots: See Annex Distribution List.

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.

Research indicates that previous batches of the VITROS® 25-OH total vitamin D calibrator may have been equally affected by this problem, and therefore recommend that previously reported results be generated using VITROS® 25-OH vitamin D total calibrators , Lots 0091 to 0235. The laboratory may wish to review the quality control results used to verify deviations in calibration. Results lower than the target mean may indicate potentially biased test results. Discuss any concerns with the Laboratory Medical Director or the doctor who requested the examination. The results from this or any other diagnostic test should be used and interpreted only in the context of the whole clinical picture. The company informs that this event fits into the situation whose use of, or exposure to, the affected product may cause adverse health effects that are clinically reversible or temporary, or in which the likelihood of serious adverse health consequences is remote, as defined in legislation relevant.