Events

Safety Alert for Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC Reactive CRP Technical Name: C Reactive Protein / Protein C Reagent ANVISA Registration Number: 10132590348 Hazard Class: II Affected Model: Box with 5 cartridges x 50 slides / Box with 5 cartridges x 18 slides Serial Numbers Affected: VITROS Chemistry Products PCR Slides; Product Codes: 1926740 and 8097990. Considering the scope of the affected lots (already distributed and possible commercialization), the list of customers using the inputs affected by this field action was considered based on the equipment purchased.

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
    2112
  • Date
    2016-11-28
  • 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
    Follow the instructions in the alert letter to perform dilutions when processing samples above the PCR measurement range. VITROS PCR Slides Instructions for Use (IFUs) will be revised to include additional instructions to follow when diluting samples with results above the measurement range. Meanwhile, keep the notification as verification of the reviewed process for processing samples above the measurement range.
  • Reason
    Ortho clinical diagnostics (ortho) received pcr reports with positive deviation when using vitros pcr slides for sample dilution. vitros chemistry products pcr slides products quantitatively measure c-reactive protein (crp) concentration in serum and plasma using the vitros 250/350 / 5.1 fs and 4600 systems and the vitros 5600 integrated system.
  • Action
    Field Action Code 16000165 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

Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC...

Manufacturer

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