Events

Safety Alert for Trade name: ACCELERATOR - Accelerator 3600. ANVISA registration number: 80146501830. Hazard class: I. Lots - does not apply. Batch Affected Quantity: 2

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; INPECO SA..

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
    2024
  • Date
    2016-06-13
  • 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
    According to company information: Do not exceed the maximum of 3500 RPMs. This corresponds to an RCF (g) value of 2657. This value meets the centrifugation requirements of the most commonly used blood sample tubes: min) * Manufacturer: BD / Type: Vacutainer / RCF *: 1100-1300 / Time 10/15 • Manufacturer: Greiner / Type: Vacuette / RCF *: 1800 - 2200 / Time (min) *: 10 • Manufacturer: Sarstedt / Type: S- min) *: 10 - 15 * Follow the instructions for use of the respective tube manufacturer. You may need to adjust the set spin time. WARNING: Reduction of RPMs may impact overall workflow and run times due to potential increase in spin time. 2. Additional information in the letter sent to the client attached to this notification. Your local Abbott representative can assist you in providing replacement products, financial credit and / or recommended alternative solutions. All future lots will have an appropriate shelf life before delivery. 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
  • Reason
    Inpeco recommends an immediate reduction in the speed of operation of the centrifuge so as not to exceed the maximum of 3500 rpms. material changes may have had an impact on bucket force, which could lead to bucket displacement in the centrifuge. there are no accelerator a3600 customer reports of any failures with the centrifuge module. however, if the centrifuge fails, there is potential for: - operator exposure to biological risk (due to broken sample tubes) - operator injury (caused by glass broken inside the centrifuge or by unexpected centrifugal movement).
  • Action
    Field Action No. FA19MAY2016A, triggered under the responsibility of the company Abott Laboratories. Field action risk classification: III Field action classification: Field correction

Device

Trade name: ACCELERATOR - Accelerator 3600. ANVISA registration number: 80146501830. Hazard class...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA; INPECO SA.
  • 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