Events

Safety Alert for Trade Name: IRISpec CA / CB / CC; registration number 10033120952; risk class II; lot / series: 004-16 (distributed as follows: 1 in Ceará, 5 in Rio de Janeiro, 3 in Espírito Santo, 2 in Paraná, 1 in Santa Catarina, 1 in Minas Gerais, 34 in São Paulo, 1 Pará, 6 in Maranhão and 2 in Bahia).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Beckman Coulter do Brasil Comercio e Importação de Produtos para Laboratório Ltda; IRIS Diagnostics a Division of Iris Internacional 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
    1872
  • Date
    2016-05-02
  • 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
    Recommendations to Users and Patients: If the laboratory is using any of the listed batches: • Follow the instructions for handling and storing the quality control material in accordance with the product's current package insert (IFU) to avoid premature degradation due to the technique inadequate. Bulletin Number (IFU) 300-1223. • If the IRISpec CA control for the bilirubin parameter fails, discard the vial and use another vial of the same control that accompanies the kit. Each kit consists of 3 vials of the AC control. • If the problem persists, request product replacement by contacting the customer service area at 11 4154-8818 or lmanzan@beckman.com
  • Reason
    On 12.04.2016 beckman coulter of brazil received beckman coulter inc. from its parent company, an email with an important product notice, reporting a problem regarding the premature degradation of bilirubin for some specific batches may lead to failures in the bilirubin control material in the irispec ca product. - irispec ca control may fail for specific bilirubin analyte. -the laboratory will be unable to process the patient samples until the approvals of the quality control (qc). -not all bottles within a specific lot may be affected.
  • Action
    Action code IPN-25316. Letter with instructions for customers /// If problem persists with lot 004-16, registration holder will start collecting the product.

Device

Trade Name: IRISpec CA / CB / CC; registration number 10033120952; risk class II; lot / series: 0...

Manufacturer

Beckman Coulter do Brasil Comercio e Importação de Produtos para Laboratório Ltda; IRIS Diagnosti...