Events

Safety Alert for PSA Third Generation IMMULITE® / IMMULITE® 1000 - Registration 10345160987. Lots: 320 and 321.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    1291
  • Date
    2013-09-03
  • 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 analysis identified that the severity is insignificant, because as the controls of the assay are out of range, adjustment will occur, preventing the release of patient results. There is no impact to patient samples when values ​​are not reported, so this action is classified as without health risk. Letter to the client: http://portal.anvisa.gov.br/wps/wcm/connect/6c0ba8804115b1d2aed3af0ea338d2ac/Carta_aos_clientes_+IMC_13_20.pdf?MOD=AJPERES
  • Reason
    Adjustment faults with the 3rd generation immulite® / immulite® 1000 psa kits (lkup1) of batches 320 and 321. some kits may contain committed (lupl / h) patch paths of lot 0126, which may lead to adjustment faults and / or exceed the established interval. if the adjustment is correct, the quality control results within the established range, the kit can be used to release patient results.
  • Action
    Customers were instructed to discontinue use of the product, segregate any remaining stock from the affected lot of the Third Generation IMMULITE® / IMMULITE® 1000 PSA in order to return these products to Siemens and keep the letter with the laboratory records.

Device

PSA Third Generation IMMULITE® / IMMULITE® 1000 - Registration 10345160987. Lots: 320 and 321.

Manufacturer

Siemens Healthcare Diagnostics Products Ltd
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA