Events

Safety Alert for TROPONIN I TURBO IMMULITE / IMMULITE 1000, Kit for 100 tests, Registration 10345160677, lots 0319; 0321; 0322 and 0323.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products Ltd.

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
    1482
  • Date
    2014-11-26
  • 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
    The overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as a medium risk to health, its severity being moderate and its probability of occurrence probable. The use of the batches of affected reagents may lead to an increase in the frequency of falsely elevated troponin values. Quality control is unlikely to detect this problem. A falsely elevated troponin value may lead to additional treatment or unnecessary diagnostic procedure. Siemens is recommending a review for any troponin sample that is in the sample stability period, and with troponin values ​​higher than the cut-off established by the laboratory, or greater than the 99th percentile, and which has not been confirmed by another method.
  • Reason
    Siemens confirmed that troponin i turbo immulite / immulite 1000 reagents, batches 319, 321, 322, and 323 demonstrated an increase in the frequency of 2-7% in the number of falsely elevated troponin values ​​in patient samples above the 99th percentile > 0.30 ng / ml (μg / l) as published in the instructions for use. quality control is unlikely to detect this problem.
  • Action
    The company advises customers to discontinue use of the product, segregate any remaining stock from the affected lot of Troponin in order to return these products to Siemens and keep the letter with the laboratory records. In addition, Siemens recommends retaining the letter with the laboratory records and forwarding the notification to anyone who may have access to the products.

Device

TROPONIN I TURBO IMMULITE / IMMULITE 1000, Kit for 100 tests, Registration 10345160677, lots 0319...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products Ltd
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA