Events

Alerte De Sécurité sur ARCHITECT FREE T4 REAGENTS Technical Name: FREE THYROXIN ANVISA Registration Number: 10055311070 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 65349UI00; 65349UI01; 68194UI00; 68194UI01; 68196UI00; 68196UI01; 71292UI00; 71292UI01; 71374UI00; 71374UI01; 5415UI00; 68241UI01; 70273UI01; 71339UI00; 73200UI01; 74137UI00; 65415UI01; 68241UI00; 70273UI00; 71339UI01; 73200UI00; 74137UI01.

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 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
    2298
  • Date
    2017-05-22
  • 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
    Results from patient samples between 5.00 ng / dL and 6.00 ng / dL should be reported as> 5.00 ng / dL. Review this release with your laboratory manager and discuss the potential impact on your laboratory's specific procedures, such as internal ranges. 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. Keep this notice in your lab files. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Change in the range of the architect free t4 assay, list numbers 7k65-29, 7k65-34 and 7k65-39. recent data generated by abbott have determined that the measurement range is from 0.40 ng / dl to 5.00 ng / dl. a measurement range is defined as the range of values ​​in ng / dl that meet acceptable performance limits for inaccuracy and linearity. the current measurement range for the list numbers 7k65-29, 7k65-34 and 7k65-39 is from 0.40 ng / dl to 6.00 ng / dl. a new ft4 test file and updated usage instructions will be created to reflect the new measurement range from 0.40 ng / dl to 5.00 ng / dl for use with the list numbers 7k65-29, 7k65-34 and 7k65-39.
  • Action
    Field Action Code FA28APR2017 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ARCHITECT FREE T4 REAGENTS Technical Name: FREE THYROXIN ANVISA Registration Number: 10055311070 ...

Manufacturer

Abbott Laboratórios do Brasil; 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