Events

Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high calibrator; 2 vials (5.0 mL / vial) of low calibrator. Kit containing: 6 vials (5.0 mL / vial) of high gauge; 6 vials (5.0 mL / vial) of low calibrator //// Registration: 10345160165, hazard class II. Affected lots: 40978A84; 41239A84; 41846A84; 44162A84; 47938A84; 51961A86; 53232A86; 55812A86; 95551A87; 07628A87; 18026A87. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc. 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
    1720
  • 날짜
    2015-10-28
  • 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
    Siemes Healthcare identified that these observed differences would not affect patient diagnosis or monitoring, although failures in 1: 4 and 1: 8 dilution recoveries with Calibrator A could affect T4 accuracy levels above the assay range .
  • 원인
    Siemens healthcare diagnostics proactively conducted a customer notification regarding 1: 4 and 1: 8 manual dilution recovery in the advia centaur t4 assay, used in the advia centaur xp, advia centaur xp, advia centaur xp and advia centaur cp systems. siemens has identified that recovery percentages for dilutions of patient samples 1: 4 (with calibrator a prior to the batches terminated at 84 and 86) and 1: 8 (batches terminated at 84, 86 and 87) are lower than the advia centaur t4 instruction for use. (see attached).
  • 조치
    Correction of Instructions for Use The company will: discontinue the use of 1: 8 manual sample dilutions of T4 samples on ADVIA Centaur systems. /// Manual dilutions 1: 2 and 1: 4 can be performed for T4 samples with results above the assay range for Batches of Calibrator A terminated at 87 and above. It was confirmed that these dilutions performed as expected. /// Batches of Calibrator A terminated at 84 and 86 may continue to be used for all other assays requiring Calibrator A, except for dilutions of T4 samples. (SEE ANNEX) .Code of Action: CN CC 15-14.

Device

Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.