Safety Alert for Trade Name: MagNA Pure 24 System. Technical Name: Instrument for analysis of nucleic acids. ANVISA registration number: 10287411309. Risk Class: II. Model Affected: N / A. Serial numbers affected: Active: 1119 | Inventory: 1162

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    The company informs customers that in most cases, labs do not need to review past results or retest patients because cross-contamination and the generation of false positive results are usually rare and require the presence of a high titre sample in the battery tested. It states that if the samples were tested for the diagnosis of acute and self-limited conditions, there would be no benefit to the patient from a retrospective review of previous results or a retest. It reports that a review of previous results is relevant only in cases where the MagNA Pure 24 Pathogen (200 and / or 1000) protocols were used to extract nucleic acids for an assay of a chronic infectious disease (eg hepatitis C) and one change in outcome could affect treatment outcome. Reports that suspected false positive results that could potentially affect patient behavior should be retested according to local procedures using the MagNA Pure Instrument with the recently released Pathogen200 hp or Fast Pathogen 200 protocols or the External Lysis Pathogen 200 and 500 protocols or an alternative method. It states that since cross-contamination and the generation of false positive results are considered rare and require the presence of a high titre sample (unlikely frequency), until the updated Pathogen200 and Pathogen1000 protocols are available, users can: 1. Use the newly released Pathogen200 hp or Fast Pathogen 200 protocols or the External Lysis Pathogen 200 and 500 protocols, if available in your country; 2. Use an alternate method for testing purposes. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa / notivisa). 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 Complementary Information: - Date of identification of the problem by the company: 04/13/2018 - Date of notification notice to Anvisa: 05/11/2018 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. (...) "
  • Reason
    The company holding the registration informs that a risk of cross-contamination of samples for the pathogen200 protocol in the magna pure 24 system, reported by an external customer, has been identified. the internal investigation performed by the manufacturer confirmed the event reported by the client in the pathogen200 and pathogen1000 protocols. the company detected that cross-contamination of samples during the extraction of nucleic acids from pathogens can generate false-positive results or overestimated values. false positive or overestimated results can lead to unnecessary medical treatments or side effects with a likelihood that the company is remote from creating adverse health consequences. some pathogens such as hepatitis b (hbv) may be present in titers in excess of 10e9, and therefore even small contamination may result in erroneous results.
  • Action
    Field Action Code SBN-RMD-2018-001 under the responsibility of the company Roche Diagnóstica Brasil Ltda. Update of Pathogen200 and Pathogen1000 Protocols.