Safety Alert for Trade name: BC Thrombin Reagent. Technical Name: Thrombin Time (TT). ANVISA registration number: 10345161613. Class of risk: II. Affected model: Reagent: 10 x 5 mL (lyophilized) / Buffer solution: 1 x 50 mL. Serial numbers affected: 46751, 47184

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.

Comparison with previous value is not recommended as haemostatic parameters vary over time and the results at the time point of the past measurement may not reflect the current status of the patient. Each laboratory should establish its own reference ranges or verify them whenever one or more of the variables mentioned above are changed. The affected lots respond more sensitively, presenting 20% ​​longer TT results. This will lead to an increase in the rate of results above the reference range if not adjusted. Therefore, adjustment of the laboratory specific reference ranges is recommended when switching to a new batch of reagent according to the Thrombin Time Application Sheet with BC Thrombin if it is used as a screening test for inhibition of thrombin. If affected batches of the BC Thrombin kit are used to control fibrinolytic therapy and / or levels of heparin and thrombin inhibitors, ranges or therapeutic ranges should be adjusted accordingly. Siemens reports that TT exhibits a non-linear but hyperbolic dose-response relationship. If you need support for these special applications, you should contact technical support. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/10/2017 - Date of notification notice to Anvisa: 09/11/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "