Events

Safety Alert for Trade name: iChem VELOCITY Technical name: Urine Analyzer Instrument ANVISA Registration Number: 10033129046 Hazard Class: I Affected Model: Serial Numbers Affected: All instrument serial numbers in Brazil are affected by this notification.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Beckman Coulter do Brasil Comércio 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
    2218
  • Date
    2017-02-24
  • 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
    • Avoid hitting the probe during maintenance or troubleshooting. • Carefully follow the instructions in the Operator's Manual, PN 301-7146 or 300-4449, to: - Use the Probe Safety Latch. - Use approved pipe types. - Remove tube caps prior to sample analysis to avoid probe-tube collisions. • As a temporary measure, perform a patient cross-check or perform QA after performing maintenance or troubleshooting in the sample probe area. If you have any questions about the results, please contact our Customer Service Center. • Consult the Laboratory Director to determine if a retrospective review of the results is medically justified.
  • Reason
    On 31.01.2017, beckman coulter of brazil received beckman coulter inc. from its parent company, an email with an urgent medical device recall notification, stating that iris international has determined that misalignment of the sample probe or probe damaged in ichemvelocity can lead to a remote possibility of falsely negative results due to improper dosing of the strip. the investigation was initiated on the basis of customer complaints for control failures.
  • Action
    Field Action Code FA-17006 triggered under the responsibility of Beckman Coulter of Brazil Trade and Import of Products for Laboratório Ltda. Company will make correction in the field.

Device

Trade name: iChem VELOCITY Technical name: Urine Analyzer Instrument ANVISA Registration Number: ...

Manufacturer

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