Events

Alerte De Sécurité sur ARCHITECT SHBG REAGENT / ARCHITECT SHBG REAGENT Technical Name: GLOBULIN-CONTAINED SEXUAL HORMONE (SHBG) ANVISA Registration Number: 80146501359 Hazard Class: II Affected Model: Not applicable Affected serial numbers: 01916E000, 00316F000, 01816G000, 00916I000 , 07316I000, 00916L000, 01816E000, 00216F000, 01716G000, 00816I000 and 07216I000.

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 GmbH & Co. KG..

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
    2297
  • 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
    1) Immediately discontinue the use of potassium EDTA-type tubes with the ARCHITECT SHBG assay according to your laboratory procedures. 2) Review this statement with your Medical Officer to ensure that he or she is aware of the problem and to decide whether a review of previously generated results is required using potassium EDTA-type sample tubes. 3) 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. 4) Please complete and submit the Customer Response Form. 5) Keep a copy of this statement 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
    Abbott has identified that the results of the architect shbg assay generated with the potassium edta-type tube may demonstrate a negative change from the results generated with serum samples. disruption of shbg dimer in edta may result in low shbg measurements by immunoassays *. all currently valid batches of reagent stock are impacted. * fillmore cm, fear tr, hoover rn et al. biomarkers: biochemical indicators of exposure, response, and susceptibility to chemicals. biomarkers 2000; 5 (5): 395-398.
  • Action
    Field Action Code FA18APR2017 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ARCHITECT SHBG REAGENT / ARCHITECT SHBG REAGENT Technical Name: GLOBULIN-CONTAINED SEXUAL HORMONE...

Manufacturer

Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG.
  • 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