Alerta De Seguridad para ADVIA CENTAUR TSH3-Ultra (TSH3-UL), Registration No. 10345161732 - Lots: 20614266; 20789266; 21060266; 22006266; 23675267; 23790267; 23971267; 24111267; 24509267; 25222267; 26377269; 26425269; 26725269; 27005269; 28270269; 29642270; 31163270; 32453271; 32953271; 3,420,527; 34987272; 35288272; . ADVIA CENTAUR VITAMIN D TOTAL (VIT D), Registration nº 10345161800 - Kit for 100 tests: Lots 20704023; 21215023; 21656023; 24042023; 25822024; 26961024; 28118025; 28507025; 31757026; 32787026 and Kit for 500 tests: Batches: 20640023; 21368023; 22792023; 26324024; 31817026; 34098026; 35698027; . ADVIA CENTAUR VITAMINA D TOTAL, Registration nº10345161889 - Lots: 33093052; 35197053; . ADVIA CENTAUR PROCALCITONIN (PCT), Record 10345161790 - Lots: 28917023; 31219024.

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 company reports that, according to the manufacturer's research fluorescein has shown impact on TSH, Vitamin D and Procalcitonin results. This compound is used systemically to aid in angiographic imaging. Fluorescein angiography is a low-frequency procedure and is unlikely to occur coincidentally with testing for thyroid function, vitamin D, or clinical levels of procalcitonin. Based on risk analysis and mitigation, it was determined that the probability of occurrence is extremely unlikely, being P <0.000001 and lower severity in which it may lead to a temporary adverse consequence, which fits this situation as without health risk. The company further clarifies that falsely low values ​​of TSH3 Ultra can be found in patients who were injected with fluorescein sodium before the TSH test. These values ​​are important in the monitoring of thyroid cancer, since the doctor can determine that adequate thyroid suppression has been obtained. TSH levels are used to diagnose thyroid dysfunction in conjunction with fT4 and fT3, which would not coincide with the suppressed TSH result, leading to further investigation. False-high values ​​of Vitamin D will lead to further investigation, as it is unlikely to achieve such results without Vitamin D supplementation. False-reduced values ​​of Procalcitonin will lead to patient observation because, in case of suspected sepsis, the patient should be monitored clinically and biochemically and microbiologically tested.