Events

Alerte De Sécurité sur CREATININE PAP FS-R1 1x800 ml + R2 1x400 ml; R1 4x100 ml + R2 2x100 ml; R1 6x40 ml + R2 6x20 ml - 2040 automated determinations; R1 4x34.9 mL + R2 4x19.3 mL - 800 automated determinations - ALL IMPORTED LOTS.

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 BIOSYS LTDA.

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
    1183
  • Date
    2012-09-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    There is a median probability of an incorrect creatinine value occurring in urine samples from patients with alkaptonuria (due to homogentisic acid). The severity and estimated risk is low if the test results are assured by the laboratory's internal quality control. The results of the tests should be checked critically by the health professional. Anvisa accompanies this Action. #### TERMINATION - 03/10/2012 - The company forwards Notice of Completion of the Field Action.
  • Cause
    High concentrations of hga in urine samples may interfere with photometric measurement with the enzymatic creatinine method and to a lesser extent with the jaffé method.
  • Action
    The results of the tests must be ensured by the internal quality control of the laboratory. The results of the tests should be checked critically by the health professional. In addition, the health professional should evaluate the need for confirmatory tests, as well as take into consideration the patient's medical history and examination. In case of a discrepant result with the patient's clinic, confirm the result using a different method. Check the instruction for use of the product to evaluate information on possible interference.

Device

CREATININE PAP FS-R1 1x800 ml + R2 1x400 ml; R1 4x100 ml + R2 2x100 ml; R1 6x40 ml + R2 6x20 ml -...

Manufacturer

BIOSYS LTDA
  • Société-mère du fabricant (2017)
    Biosys Ltda
  • Source
    ANVSANVISA