Events

IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20). IMx HIV-1 HIV-2 III Plus Controls (List No. 8C98-12). Westen Blot HIV Blot 2.2 (List # 2F02-01 and 8E02-01) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATORIOS DO BRASIL LTDA. 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
    527
  • 날짜
    2002-03-19
  • 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
    Brazil - 03/14/2002, the company informs that it has followed the program of product collection, through verbal communication measures to all customers, started on January 28, 2002; Formal communication initiated on 01.02.2002, sent to clients; correspondence sent to distributors. Products Collected: Western Blot HIV Blot 2.2 - No. 2F02-01, lots # AE0087, AE0088, AE0098, AE0100. AE0101 and AE1006. Western Blot HIV Blot 2.2 - List # 8E02-01 - Lots numbers: AE1021, AE0102, AE0096, AE1001, AE1008, AE1011, AE1017, AE1024, AE1031 and ae1034. IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20) - Lots numbers: 78172LU03, 80180LU01, 80180LU03, 80180LU04 and 81246lU03. IMx HIV-1 HIV-2 III Plus Controls (List No. 8C98-12) - Lots numbers: 76085HP00 and 80346HP00.
  • 원인
    Unsatisfactory for internal labels and instruction manual, for not presenting information in portuguese according to bulletin of analysis nº 4157.00 / 01, nº 4158.00 / 01, n ° 4159.00 / 01 and 4160.00 / 01 of the incqs.
  • 조치
    The Technical Board of the Sanitary Surveillance Center of the State Health Secretariat SÃO PAULO, through CVS 27/02 - GT 4 DITEP, notified that the results of the analysis of these products revealed unsatisfactory. It determined the prohibition of marketing and use of all the units of the batch of the product in question, collection by the undertaking of all units of the batch marketed and other supplies under the same conditions; presentation by the company of the report on the payment made to the local VISA; that the establishments acquiring the products of the said company make due notification to corresponding regional VISA for complementary measures.

Device

IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20). IMx HIV-1 HIV-2 III Plus Controls (List No....

Manufacturer

ABBOTT LABORATORIOS DO BRASIL LTDA.
  • Source
    ANVSANVISA