Safety Alert for VITROS IMMUNO-DIAGNOSTIC REAGENT PACKAGES: (1) FERRITIN, (2) TOTAL B-HCG

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ORTHO-CLINICAL DIAGNOSTICS INC A JOHNSON & JOHNSON CO..

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
    68
  • Date
    2001-05-14
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Reagent bottle is badly positioned. this bad position causes very lackable light signals, resulting in calibration failure, error code or results of 0,0 ng / ml. the distributor began a letter correction and a temporary review of the quality control protocols.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE LETTER AND THE TEMPORARY REVISED QUALITY CONTROL PROTOCOLS OF JANUARY 26, 2001 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. IMPLEMENT THE TEMPORARY PROTOCOL ON ALL AFFECTED PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.

Manufacturer