Events

Alerte De Sécurité sur AxSYM Troponin-I Reagents, Anvisa Record nº 10055310760 List numbers 3C29-15 and 3C29-20, all batches.

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 Abbott Laboratórios do Brasil Ltda - Divisão Diagnosticos.

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
    773
  • Date
    2004-05-31
  • 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
    The revised quality control procedure for low control is as follows: Analyze a single sample of a low control No abbott once every four hours. The control should have a manufacturer-reported mean of less than 2.0 ng / mL (ug / L) when tested with the AxSym Troponin-I Reagent Assay. If you can not test a non-abbott low control, use a sample. The concentration of this sample should be representative of its patient population; i.e., the target should be <0.3 ng / mL (ug / L). If the concentration of this healthy sample changes out of the normal range (> 0.5 ng / mL (ug / L) recalibration is required. For additional information call Customer Service Center 0800 11 90 99.
  • Cause
    Reporting of a high result trend for the axsym troponin-i reagents within 24 hours cumulative before re-calibration of the assay. fact reported in healthy patients, in the range of 0.5 ng / ml or less.
  • Action
    Abbott is reviewing the quality control procedure for low control, which will allow the detection of change in the results around the cutoff for acute myocardial infarction (AMI) of 2.0 ng / mL. The company started communication to customers on 04/27/2004, by means of letter and protocol of customer response. In case the AxSYM Troponin-I Reagent product has been sent to other laboratories, please inform by means of forms sent by Abbott Laboratories of Brazil Ltda - Diagnostics Division (FA27APR2004)

Device

AxSYM Troponin-I Reagents, Anvisa Record nº 10055310760 List numbers 3C29-15 and 3C29-20, all bat...

Manufacturer

Abbott Laboratórios do Brasil Ltda - Divisão Diagnosticos
  • Source
    ANVSANVISA