Events

Safety Alert for Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex 1 Technical name: Reag for immunohematology - Red cell reagent / enzyme-treated red cell number ANVISA registration number: 80145901444 Hazard class: : Surgiscreen -Conj of 3 vials with 3mL each of cel for detection of unexpected antibodies Serial numbers affected: 3SS214Z; 3SS216Z; 3SS222Z; 3SS225Z; 3SS231Z; 3SS238Z; 3SS241Z; 8EA329; 8RA330; 8RA331; 8SS282; 8SS284; 8SS285; 8SS286; 8SS271; 8SS272; 8SS273; 8SS274; 8SS275; 8SS276; 8SS277; 8SS278; 8SS279; 8SS280; 8SS281; 8RC306; 8RC307; 8RC308; 8S893; 8S894; 8S896; 8ª511; 8ª512; 8ª222; 8ª523; 8,548; 8ª534.

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
    2114
  • Date
    2016-12-02
  • 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
    • Visually inspect all products before use according to the Instructions for Use. Do not use red cell products if marked haemolysis or evidence of contamination is observed. • Contact the Ortho Care ™ Technical Solutions Center to report a product in which marked haemolysis has been observed so that the product can be replaced or credited. • Complete and return the Receipt Confirmation form.
  • Reason
    Ortho clinical diagnostics received a large number of customer complaints and confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products, as well as quality control products containing red blood cells. ortho conducted extensive research and the root cause for marked haemolysis was identified as microbial contamination.
  • Action
    Field Action Code 16000162 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

Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex ...

Manufacturer

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