Events

Safety Alert for Commercial Name: Architect Dhea-S Reagent Kit / Architect Dhea-S Reagent Kit. Technical Name: Dehydroepiandrosterone Sulfate (DHEA-S). ANVISA registration number: 80146501346. Class of risk: II. Affected Model: Not applicable. Serial Numbers Affected: 01316K000; 01217A000; 02217D000; 04117H000; 01216K000; 01117A000; 02217C000; 02317D000; 02417D000; 00517F000

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil Ltda; 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
    2465
  • Date
    2017-01-11
  • 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 use of the ARCHITECT DHEA-S assay with samples of children up to 60 days of age. 2) Immediately discontinue the use of representative data from the Expected Values ​​section of the ARCHITECT DHEA-S reagent instructions for children up to 10 years of age. 3) Review this statement with your medical director and follow your laboratory protocol regarding the need to review patient outcomes already reported. 4) 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. 5) Please complete and submit the Customer Response Form. 6) Keep this statement in your lab files. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/14/2017 - Date of notification notice to Anvisa: 11/01/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    The purpose of this announcement is to inform you about a product correction for the architect dhea-s assay and to provide instructions on what action should be taken by your laboratory. abbott has identified that falsely elevated results can be obtained by using the architect dhea-s assay with samples of children up to 60 days of age. the specific cause of high outcomes is being investigated. although high results have been observed only with samples of children up to 60 days of age, data representative of the expected values ​​section for children up to 10 years of age provided in the instructions for use of the architect dhea-s assay should not be used because these reference ranges are being reviewed as part of the research.
  • Action
    Field Action Code FA14DEC2017 triggered under the responsibility of Abbott Laboratórios do Brasil Ltda. Will make field correction

Device

Commercial Name: Architect Dhea-S Reagent Kit / Architect Dhea-S Reagent Kit. Technical Name: Deh...

Manufacturer

Abbott Laboratórios do Brasil Ltda; 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