Events

Safety Alert for VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR T4TOTA L, Registration nº 10132590390 and VITROS IMUNODIAGNOSTIC REAGENT KIT * ECi FOR TOTAL T4, Registration nº 10132590400 - lot 1590 - See Annex 1 - Distribution List

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1366
  • Date
    2014-02-25
  • 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 informs that if the service identifies this problem, the VITROS ® System may have had a calibration failure or have presented lower than expected quality control results after the successful calibration of Lot 1590. If the control results are negatively biased, suspect that patient outcomes have been affected, consult your medical director in your laboratory to address any concerns you may have regarding the results of previously reported patients. The company informs that this is a situation in which the use or exposure to the affected product may cause temporary or clinically reversible adverse health consequences, or where the likelihood of a serious adverse health consequence is remote
  • Reason
    The registrant reports that lower than expected quality control results have been observed using vitros ® total t4 reagent packs, lot 1590. results from the patient sample may also have been affected as the quality control results. there were reports of inability to calibrate by using vitros ® total t4 calibrators, lot 1590.
  • Action
    The company directs customers to immediately discontinue the use of all units in inventory of VITROS® Total T4 1590 batch and reagent pack. Lot 1590 should be discarded from inventory. The quality control results generated from Lot 1590 should be analyzed. If quality control results are negatively biased and patient results are suspected, the service should consult with your Medical Director in your laboratory to resolve any concerns you may have regarding the results of previously reported patients. Further information in a letter to the Client (Annex 2)

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR T4TOTA L, Registration nº 10132590390 and VITROS IMUN...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda