Events

Safety Alert for CORTISOL, LIAISON CORTISOL, record 10339840213, affected lot numbers: 244511X; 244521X; Risk class II

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DiaSorin Ltda.; DiaSorin S.p.A..

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
    1709
  • Date
    2015-10-02
  • 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
    According to the registry holder, if the values ​​of the controls are outside the new ranges informed, the results need to be reviewed and informed to the clinician and according to the instructions for use of the product, patient results can only be interpreted in the answer to the table clinical and other diagnostic procedures.
  • Reason
    When the following bio-rad controls are used: lyphocheck immunoassay control, lot # 40310; liquicheck urine chemistry control, lot # 66700; lyphocheck quantitative urine control, lot no. 63350; in conjunction with the liaison cortisol kits for lots 244511x and 244521x, the values ​​and the theoretical ranges reported in the bio-rad leaflet are not appropriate. in these cases, the values ​​of the controls need to be changed in accordance with the attached technical note.
  • Action
    Change control ranges if using the BIO-RAD controls of batches reported above. According to the company, the results already released need to be revised according to the results of the controls, if they were with the values ​​within the new ranges informed, no action is necessary if the results of the controls are with the results outside the new ranges the routine needs to be considered invalid by reviewing the sample values. Action code: FSN-29092015-1.

Device

CORTISOL, LIAISON CORTISOL, record 10339840213, affected lot numbers: 244511X; 244521X; Risk clas...

Manufacturer

DiaSorin Ltda.; DiaSorin S.p.A.