Events

Safety Alert for VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR TSH - registration 10132590384 (code: 1487289) and VITROS ECI FOR IMMUNODIAGNOSTIC REAGENT KIT FOR TSH - Registration 10132590403 (code: 1912997) - Lot 4540. 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; Ortho-Clinical Diagnostics.

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
    1415
  • Date
    2014-08-13
  • 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 manufacturer informs that according to international regulations, this event falls into a situation in which the use of, or exposure to, the affected product is unlikely to result in adverse health effects. The inability to generate successful calibration with VITROS® TSH Calibrators and Reagent Packs, Lot 4540 only affects the VITROS® 5600 and VITROS® 3600 Systems. If the laboratory has successfully calibrated the VITROS® TSH Calibrators and Reagent Packs products, Lot 4540 , the VITROS® 5600 and / or VITROS® 3600 System and the quality control results are acceptable, there will be no impact on patient outcomes.
  • Reason
    Ortho clinical diagnostics (ocd) has received complaints from customers who failed to generate a successful calibration using vitros® tsh calibrators and reagent packs, lot 4540, on the vitros® 5600 and 3600 systems. the company reports that it has not received calibration failures on the vitros® eci / eciq systems.
  • Action
    The company informs that: i - If the laboratory has a VITROS® ECi / ECiQ System, it is possible to continue using VITROS® TSH Calibrators and Reagent Packs, Lot 4540, in the VITROS® ECi / ECiQ System. The OCD recommends that you allocate the remaining inventory of Lot 4540 for use only in the VITROS® ECi / ECiQ System; ii - If the laboratory has only VITROS® 5600 and / or VITROS® 3600, OCD will credit the account or replace the remaining customer inventory of VITROS® TSH Calibrators and Reagent Packs, Lot 4540 if you are unable to use this lot in a VITROS® ECi / ECiQ System; iii- If you have successfully calibrated VITROS® TSH Calibrators and Reagent Packs, Lot 4540, you can continue to use the current inventory until you receive the replacement product as long as the quality control results for TSH are acceptable; iv - To avoid this failure again in the future, discontinue use and dispose of all VITROS® TSH Calibrators and Reagent Packs, Lot 4540, after receiving the replacement product. For more information, please check the Letter to the Client - Annex II

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR TSH - registration 10132590384 (code: 1487289) and VI...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics