Events

IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710 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
    757
  • 날짜
    2003-11-25
  • 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
    Recommendations: 1 - Identify if the product IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710 is in use or in stock. 2 - Discontinue use of the IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry no. 10055310710. Store this material in your laboratory for later return to Abbott Laboratories - Diagnostics Division. 3 - Fill in the Response Protocol and send to fax 0xx11 - 5536 7181, for the subsequent return of the product. The company will collect the material and provide a refund. If you have any further questions or concerns, please contact the Customer Service Center at 0800 119099, or contact your local representative.
  • 원인
    The product imx tacrolimus ii calibrators no. 3c10-01, lot no. 94164m100 may present instability of the calibrators during the calibration of the imx tacrolimus reagents test, generating the following messages on the imx instrument: code 157: check 1 out of range, code 159: check 3 out of range and code 161: check 5 out of range.
  • 조치
    The Abbott Laboratories-Diagnostics Division has reviewed the available data and concludes that: The use of the IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Batch No. 94164M100 may generate an increase in calibration error codes when using a few batches of the reagent IMX TACROLIMUS II Reagents (list no. 3C10-20). Results of patients who were refueled with the valid calibration curve and test control values ​​within the expected range were not affected and are considered valid. The Abbott Laboratories-Division Diagnostics is conducting research to determine the cause of this instability.

Device

IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710

Manufacturer

ABBOTT LABORATORIOS DO BRASIL LTDA
  • Source
    ANVSANVISA