Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Beckman Coulter do Brasil Comércio e Importação de Produtos para Laboratório Ltda; IRIS Diagnostics a Division of Iris Internacional Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2218
  • Date
    2017-02-24
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    • 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.
  • Cause
    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.