Alerta De Seguridad para Trade name: PTS PANELS CHOL + GLU Test Panel Test Strips. Technical Name: Total Cholesterol. ANVISA registration number: 80812770002. Class of risk: II. Affected model: 1 box with 1 vial with 25 strips of analysis and desiccant, 1 microprocessor MEMo CHIP>. Serial numbers affected: A707

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Mex Global Equipamentos para Diagnósticos Ltda; Polymer Technology Systems, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Guidance and Required Actions: 1. Do not use the remaining PTS product in your stock. 2. Share this notification with the right people in your organization and pass this information on to all sectors that use the product, including which you may have referred. Segregate remaining stock from product PTS PANELS CHOL + GLU Test Panel Test Strips, Lot A707 - Validity 28-08-2018. 3. Fill in the form attached to the RECYCLING REPORT, forwarding it to the e-mail and the orientation on the collection of the product (s) will be provided by Mex Global. 4. The products received by Mex Global will be replaced by another and under this process no cost will be levied on our customers. 5. It is imperative that your institution fill out the attached Form - COLLECTION REPORT and send it to 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: 03/15/2018 - Date of notification notice to Anvisa: 10/04/2018 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. (...) "
  • Causa
    Based on the results of internal tests with retention samples conducted by the manufacturer, polymer technology systems, inc. there is a potential loss of activity for the analyte glucose and, therefore, obtaining lower glucose related results. there are no adverse events reported and related to this product. this is a technical complaint. however, we chose to collect the product from the market as a precaution. the pts panels chol + glu test panel test strips, lot a707, valid on 28-08-2018, is being voluntarily recalled or recalled. this correction is being conducted because of potential loss of glucose analyte activity before the expiration date (august / 2018).
  • Acción
    Field Action Code 01PTSCHOLGLU A707 triggered under the responsibility of Mex Global Equipamentos para Diagnósticos Ltda. Product pickup.