Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2297
  • Date
    2017-05-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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