Tacrolimus Dimension Reagent - Registration nº 10345161332 - Class of Risk II 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.

Inaccuracy is typically characterized by one or more high TACR results after a period of equipment inactivity. Subsequent results from the same well may show results with decreased values. Falsely decreased or falsely elevated test results may lead to impaired immunosuppressive medication dosage. Increasing the dosage may cause toxicity in the patient's organ. Decreased dosage may lead to organ rejection. If used after long periods of on-board storage (> 2 days) combined with standby periods of the equipment can increase the magnitude of elevation and decrease of results, ie the reduction of on-board stability can result in inaccuracy and in the inaccuracy of quality controls and patient outcomes. Accordingly, imprecision is typically characterized by one or more high TACR results after a period of equipment inactivity. Subsequent results from the same well may show results with decreased values. High discordant results can be raised 2-fold from the expected value and discordant low values ​​can be lowered by fifty percent. The affected lots, that is, the remaining inventory of lots prior to BB4087 must be segregated for collection. As a temporary measure, in order not to interrupt the laboratory routine, lots of reagent cartridge from lot BB4087 will present an "alert card", indicating that the on-board stability is limited to 8 hours. Customers using these batches with the "alert card" should load the Flex reagent cartridges immediately prior to use and remove it after 8 hours. It is also advised not to carry more reagents than the laboratory will use within 8 hours and not pre-hydrate the Tacrolimus Dimension reagents. For further clarification: 0800 129 633. E-mail: subjects. regulatorios.br@siemens.com. Access the warning letter: http://portal.anvisa.gov.br/wps/wcm/connect/ffc77c804ff46d0b8fd3ef6d6e8afaaa/Carta+Portugues+DC+13+08.pdf?MOD=AJPERES