Events

Safety Alert for Chemistry Calibrator, 12 vials X 3 mL, Registration No. 10345160486, lot: 090445B, 090445C

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
    1310
  • Date
    2013-09-24
  • 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
    According to the company's manifestation, the slight positive change in direct bilirubin is observed in values ​​approximately ten times greater than the reference limit. In cases of hyperbilirubinemia due to hepatic obstruction, the change will have no impact on the use of the assay for diagnostic support. For instances of hyperbilirubinemia, which test is used to estimate indirect bilirubin in conjunction with total bilirubin, total bilirubin will be slightly underestimated. However, the clinical interpretation of the results will not be affected. For patients with elevated bilirubin overestimation will not impact treatment, since the values ​​will still support both diagnosis and prognosis. For determination of total bilirubin, a proportional decrease in indirect bilirubin will have no impact on the most vulnerable population - newborns due to immaturation of the glucuronidation pathway, so most circulating bilirubin will still be the indirect one.
  • Reason
    Siemens healthcare diagnostics has identified that the system specific values ​​for the direct calibrator (dbil_2) of the chemistry calibrator, batches 090445b and 090445c belonging to the advia® chemistry 1200, 1650, 1800 and 2400 systems, may cause a + 7-9% in quality control and sample recovery at 3 mg / dl.
  • Action
    The registrant in Brazil reported that customers were instructed to use the new System Specific Values ​​reassigned for the Direct Bilirubin Assay (DBIL_2) of the Chemistry Calibrators, batches 090445B and 090445C, provided in Table 2 of the notification is attached to this alert) and to keep the letter with the records of the Laboratory.

Device

Chemistry Calibrator, 12 vials X 3 mL, Registration No. 10345160486, lot: 090445B, 090445C

Manufacturer

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