Events

Safety Alert for CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383

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
    1442
  • Date
    2014-10-17
  • 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 without health risk, its severity being low and its probability of occurrence unlikely. The positive bias observed in cortisol values ​​may potentially lead to further investigation of the status of the adrenal gland. The overall health risk is negligible. Siemens does not recommend a previous review of the results for this reason.
  • Reason
    Siemens healthcare diagnostics has confirmed that the immulite / immulite 1000 cortisol kits 381, 382 and 383 demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. positive bias has also been observed in quality control materials and may result in values ​​outside the stated ranges.
  • Action
    The company advises customers to stop using the product, segregate any remaining stock from the affected lots of CORTISOL IMMULITE with the intention of returning these products to Siemens and to keep the letter with the laboratory records.

Device

CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383

Manufacturer

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