Events

Trade name: ACCELERATOR - Accelerator 3600. ANVISA registration number: 80146501830. Hazard class: I. Lots - does not apply. Batch Affected Quantity: 2 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATÓRIOS DO BRASIL LTDA; INPECO SA. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    2024
  • 날짜
    2016-06-13
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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
  • 원인
    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).
  • 조치
    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.
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “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