Events

Alerta De Seguridad para I-STAT KAOLIN ACT CARTRIDGE Technical Name: ACTIVATED COAGULATION TIME ANVISA Registration Number: 80146501500 Hazard Class: III Affected Model: Not applicable Serial Numbers Affected: Customers using software version JAMS142E.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil; Abbott Point of Care Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2228
  • Fecha
    2017-03-17
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Our records show that your installation is testing the i-STAT Celite ACT or Kaolin ACT cartridges. APOC recommends upgrading all i-STAT analyzers running the Celite ACT or Kaolin ACT test with the JAMS142G software version. This notice only affects the operation of Celite ACT or Kaolin ACT cartridges cartridges. There is no impact on other analytes. Follow the instructions included in this communication for installing the software from the included software disc or the Abbott Point of Care website. Https://www.pointofcare.abbott/us/en/offerings/support/software-license-keys/istat-system-software-update. Fill out and return the customer's response letter to acknowledge receipt of this communication and installation of the software. If you have forwarded the cartridges to another facility, provide a copy of this notice.
  • Causa
    Abbott point of care inc. (apoc) has determined that celite act and kaolin act cartridges can produce falsely low results when very high samples of coagulation time are tested. patient samples with a coagulation time measured> 853 seconds for celite and> 1134 seconds for kaolin may show results of approximately 100 to 200 seconds while using the jams142e software version. the typical therapeutic range of the i-stat act assay is 200 to 600 seconds.
  • Acción
    Field Action Code APOC2017-001 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

I-STAT KAOLIN ACT CARTRIDGE Technical Name: ACTIVATED COAGULATION TIME ANVISA Registration Number...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Point of Care Inc.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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