Events

Safety Alert for Gentamicin (Gentamicin) Technical Name: GENT2 ONLINE TDM GENTAMICIN ANVISA Registration Number: 10287410655 Hazard Class: II Affected Model: GENT2 Serial Numbers Affected: 11916601

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
    2158
  • Date
    2017-02-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    ONLINE TDM Gentamicin (GENT2) As a precautionary measure, you should stop using the ONLINE TDM Gentamicin reagent until further guidance. Any ONLINE TDM Gentamicin kits in your stock may be retained until further notice. For the time being, there is no need to dispose of products that are still expired. Roche Diagnostica is working to provide a solution as quickly as possible, allowing customers to continue to use the Roche ONLINE TDM Gentamicin assay with the Preciset TDM I Calibrator. Roche Diagnostica Brazil will inform you accordingly. Preciset TDM I (Calibrator) The Preciset TDM I calibrator can be used for all other TDM tests on cobas ce MODULAR ANALYTICS

    (except for GENT2) and also for all TDM assays (including GENTM) in COBAS INTEGRA. For the moment, there is no need to eliminate products that are still expired. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.

  • Reason
    Roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, after internal investigations, has identified an increase in patient specimen recovery of approximately 15-20% when using the online tdm gentamicin test with the recent batches of the preciset tdm calibrator i 615118, 619681, 126387, 140735. tdm controls and external quality assessment also showed a recovery recovery of approximately 15%. except for combination with tdm control series lot 125783, in which this effect was not presented. these observations were confirmed for the online tdm gentamicin reagent kits for use in cobas ce analyzers modular analytics

    .

  • Action
    Field Action Code SBN_CPS_2016_009 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Gentamicin (Gentamicin) Technical Name: GENT2 ONLINE TDM GENTAMICIN ANVISA Registration Number: 1...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH