Events

Safety Alert for LDL DIMENSION CHOLESTEROL CALIBRATOR - Lots 7HD066, 7KD027, 7LD012 and 8AD049. Registration number: 10321170610.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DADE BEHRING LTDA; SIEMENS HEALTHCARE DIAGNOSTICS INC.

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
    924
  • Date
    2008-06-16
  • 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 that owns the product registration in Brazil (Dade Behring Ltda.) Has already sent letters of information to all customers who received the aforementioned lots of the product in question. Anvisa's Technovigilance Unit is monitoring this case. #### Annex01: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_924_carta.pdf.
  • Reason
    The estimated values ​​of four product lots are incorrect. this variation may result in a false positive value of 6% to 7% relative to the control and patient samples.
  • Action
    Product users are advised to immediately recalibrate the ALDL method (using the LDL Cholesterol LDL Reagent Dimension - DF131) using the corrected and reported values ​​of the vials.

Device

LDL DIMENSION CHOLESTEROL CALIBRATOR - Lots 7HD066, 7KD027, 7LD012 and 8AD049. Registration numbe...

Manufacturer

DADE BEHRING LTDA; SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA