Events

Device Recall radioimmunoassay, total triiodothyronine 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79170
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0720-2018
  • 사례 시작날짜
    2017-07-28
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161506
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Radioimmunoassay, total triiodothyronine - Product Code CDP
  • 원인
    Siemens has identified an issue when scanning the 20 barcode for the master curve card (mcc) with advia centaur systems t3 kit lots ending in 198 on the advia centaur xpt system.
  • 조치
    Siemens sent an Urgent Medical Device Correction letter dated July 28, 2017, that was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States. On August 15, 2017 Follow-up communication was sent to all customers. For further questions, please call (508) 668-5000.

Device

Device Recall radioimmunoassay, total triiodothyronine
  • 모델명 / 제조번호(시리얼번호)
    x
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution.
  • 제품 설명
    ADVIA Centaur¿ T3 || ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA