Events

Safety Alert for COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 10132590479 / LOTS: 3151 E 3170

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    869
  • Date
    2007-05-11
  • 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 company there is record of import and distribution of affected lots, and that the company has already started the collection process with its customers and that all affected products found in stock were blocked for sale and transferred to the quarantine site. which has already identified all the products located in stock and customers, for which the products in were sent, already having been sent the notice of collection. The UTVIG - Technovigilance Unit will be monitoring the entire collection process.
  • Reason
    The ability of certain product units to provide negatively tendentious results at concentrations below 0.20ng / ml (μg / l), this failure may be reflected in negatively tending results that affect both patient samples and positive control fluid from low level. patients with very low concentrations of troponin i may be negatively tendentious and reported incorrectly as lower than the upper reference limit (url) of 0.08ng / ml (μg / l). results greater than 0.2 ng / ml (μg / l) are not affected by this failure.
  • Action
    Statement of recollection; Request to customers to discard the remaining inventory of the lots in question.

Device

COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 1013...

Manufacturer

Ortho Clinical Diagnostics