Events

Safety Alert for 25 VITRO CALIBRATOR KIT Technical Name: HIGH DENSITY LIPOPROTEIN ANVISA Registration Number: 80145900872 Hazard Class: II Model Affected: 25 VITER CALIBRATOR KIT Affected Series Numbers: VITROS Chemistry Products Calibrator Kit 25 - Code Product # 6801896 - Lot 2576

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, INC..

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
    2113
  • Date
    2016-11-09
  • 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
    • Inspect the bar code labels provided in the 25 VITROS Calibrator Kit, Lot 2576. • Dispose of the affected labels and manually program Batch 2576 by calibrating the VITROS dHDL Dry Reagents if the bar code labels indicate Lot 2575 instead of Lot 2576. • Complete the Receipt Confirmation form to record receipt of the notification.
  • Reason
    Information about the bar code labels contained in the vitros 25 calibrator kit, lot 2576, for some of the bar codes contained in the cartridge incorrectly indicates the lot as 2575 instead of lot 2576 (correct). printed bar code labels are included with the vitros calibrator kits. bar code labels are used with the automatic calibration feature when calibrating vitros 4600 or 5600 systems.
  • Action
    Field Action Code 16000152 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

25 VITRO CALIBRATOR KIT Technical Name: HIGH DENSITY LIPOPROTEIN ANVISA Registration Number: 8014...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC.