Events

Safety Alert for IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319.

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

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
    1383
  • Date
    2014-05-02
  • 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 company reports that, based on research conducted, Osteocalcin may serve as a measure of increased bone resorption in some patients. Depending on the treatment approach, osteocalcin dosing may be correlated with therapy. In some patients the risk of osteoporosis correlates with increased osteocalcin values. Low recovery of osteocalcin is not expected to impact treatment.
  • Reason
    Siemens has confirmed an average low 50% recovery in patient values ​​over the entire reported range of the immulite / immulite 1000 osteocalcin (lkon1) test in the lots listed above, and the bias may not be detected by the quality control material.
  • Action
    The company informs that customers were instructed to discontinue use of affected lots; to segregate remaining units in their inventories to collect them; discuss the alert message with the person in charge of the laboratory in order to evaluate the need to review previously released results; to complete the effectiveness verification form and to keep the letter filed with the laboratory records. For more information, see Annex I - Customer Letter.

Device

IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319.

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA