Safety Alert for Trade name: Family E-Check- Sysmex (Xn Check). Technical name: Combined parameters in the same product. ANVISA registration number: 80015490061. Class of risk: II. Affected Model: 12 Vials X3.0 Ml of Each Level (Level 1, Level 2, Level 3). Serial number affected: 7320, 8011, 8067

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.

Customers who purchased the batches of affected product were contacted via email, phone call and also mail, which explained about the change of purchased lots. In this recommendation the laboratories were advised that they can check the accuracy of the analyzer using fresh normal whole blood. For specifications, refer to the Accuracy (Repeatability) section in the Technical Information section of the Analyzer Instructions for Use. Customers were also informed that no replacement of control material is recommended at this time; and that they must distribute this Product Notice as appropriate to their laboratory staff. Finally, it was recommended to file this Product Notice as part of the Quality System of your laboratory. LETTER OF COMMUNICATION WITH THE RECOMMENDATIONS TO THE CUSTOMER IN ANNEX. 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: 01/16/2018 - Date of notification notice for Anvisa: 02/23/218 The company that owns the affected product is responsible for contacting its customers in a timely manner. 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. (...) "