Events

Alerte De Sécurité sur ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 31497UN14; 09353UN15; 45216UN15; 14596UN15; 37055UN15 and 14782UN16

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; Abbott Laboratories 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
    2161
  • Date
    2016-11-11
  • 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
    Please forward this notice to your Medical Director. Taking into account the above information, you may continue to use the ARCHITECT Lactic Acid reagent (LN 9D89-21). Complete and return the attached Customer Response Form. If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice to the laboratory in question. Keep this statement in your lab files.
  • Cause
    Abbott identified negative interference of n-acetylcysteine ​​(nac) with the architect lactic acid reagent (ln 9d89-21). the table in the customer's release and annex describes the levels of interference observed at nac concentrations of 80 mg / l (0.49 mmol / l) and 800 mg / l (4.9 mmol / l).
  • Action
    Field Action Code FA10OCT2016 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II ...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Laboratories 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