Events

Alerte De Sécurité sur Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number: 80146501834 .. Hazard Class: III. Lots: attached list .. Lot lot affected: 2.555 units .. Number of units distributed: 1.980.

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; Abbott Ireland Diagnostics Division..

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
    2023
  • Date
    2016-07-04
  • 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
    According to company information: Ask your laboratory to take the Required Measures below to reduce the possibility of incidences of calibration errors. A. Once alternative batch is available, return any remaining stock from the following lots of ARCHITECT STAT High Sensitive Troponin-I reagents. (List not attached notice). B. If your laboratory DOES NOT have a batch of alternative reagent available in stock and has generated a valid calibration curve, immediately request the reagent batch replenishment. Continue to use these batches and follow the QC procedures recommended in the instructions for use. These lots have high potential for calibration failures with continued use. If calibration failures are repeated, they will prevent your lab from generating patient results. Once the replacement reagent lot is received, return any remaining stock from the reagent lots according to your laboratory procedures. C. If your laboratory has a batch of available alternate reagent in stock, continue to use these reagents immediately and begin using the alternate reagent batch. Return any remaining stock of batches of reagents according to your laboratory procedures. Your local Abbott representative can assist you in providing replacement products, financial credit and / or recommended alternative solutions. All future lots will have an appropriate shelf life before delivery. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Cause
    Field action on reducing the shelf life of selected batches of architect stat high sensitive troponin-i reagents listed in table 1 of the customer release. predictive monitoring of quality assurance of architect stat high sensitive troponin-i reagent lots was initiated after the field action in january - ref .: fa21jan2016 (field action not applicable to brazil for not having a lot distributed in brazil). as a result, abbott has identified a potential for increased calibration failures before the expiration date. the root cause of this situation is under investigation for appropriate long-term corrective action.
  • Action
    Field Action No. FA21JAN2016 Revision 02, triggered under the responsibility of Abott. Classification of risk: III Classification of the field action: Field action - Change of validity d)

Device

Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott Ireland Diagnostics Division.
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA