Events

Safety Alert for VITROS Chemistry Products UPRO Slides, Product Code: 10132590346 Hazard Class: II Affected Model: 5 Cartridges with 18 Slides Serial Numbers Affected: VITROS Chemistry Products UPRO Slides, Product Code 6800120, Generations (GENs): 12, 13, 14, 15, 16, 17, 18.

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
    2238
  • Date
    2017-03-20
  • 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
    Actions required: • Immediately discontinue use and discard all remaining VITROS UPRO Slides products in your inventory. NOTE: Ortho will credit your VITROS UPRO Slides, VITROS Chemistry Products Calibrator Kit 10 and / or VITROS Chemistry Products UPRO Performance Verifier I & II credit to your account. • Place this notification next to each VITROS System that uses the VITROS UPRO Slides products or along with your user documentation.
  • Reason
    Ortho clinical disagnostics (ortho) has identified the potential for diverting results for urinary protein when using vitros upro slides products.
  • Action
    Field Action Code TC2016-234 / 16000189 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will collect.

Device

VITROS Chemistry Products UPRO Slides, Product Code: 10132590346 Hazard Class: II Affected Model:...

Manufacturer

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