Events

Safety Alert for Trade name: Kit Reag Immunodiag Vitros p PTH Intacto (iPTH); Calibrad Immunodiag VITROS p PTH Intact (iPTH) Technical name: intact parathyroid hormone (iPTH); Intact Parathyroid Hormone (iPTH) ANVISA Registration Number: 80145901321 Hazard Class: II Model Affected: Reag Immunodiag Vitros p PTH Intact (iPTH); Calibrad Immunodiag Vitros p Intact PTH (iPTH) Serial numbers affected: 0700, 0710, 0748, 0758 // Immunoassay Calibrator Vitros for Intact PTH (iPTH); product code 6802893; lots: 0728, 0738, 0768.

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
    2111
  • Date
    2016-10-31
  • 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
    • Until further notice, be aware of positive deviation results when using VITROS Reagent Kits for iPTH. • Talk to the Laboratory Medical Director about any questions regarding previously reported results to determine the appropriate course of action. • Place this notification on your VITROS System or along with your user documentation. • In compliance with regulatory requirements, complete the Receipt Confirmation Form.
  • Reason
    Ortho clinical diagnostics (ortho) has confirmed that the results obtained from the vitros reagent kit for ipth show positive (ie, falsely elevated) deviations compared to a commercially available alternative method. ortho observed a 40% positive shift for samples with ipth concentrations <100pg / ml, when tested with vitros reagent kits for ipth, compared to the roche elecsys pth test. the data demonstrated that this deviation was consistent across all batches still valid. due to the limited availability of samples with ipth concentrations> 100 pg / ml, the investigation may take several weeks to complete. in the best interest of clients and patients, ortho reports the preliminary results and will provide additional notifications when the final results are available.
  • Action
    Field action Code 16000147 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Trade name: Kit Reag Immunodiag Vitros p PTH Intacto (iPTH); Calibrad Immunodiag VITROS p PTH Int...

Manufacturer

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