Events

ADVIA Centaur Intact PTH (iPTH) Assay 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
    60321
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1186-2012
  • 사례 시작날짜
    2008-10-03
  • 사례 출판 날짜
    2012-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105030
  • 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, parathyroid hormone - Product Code CEW
  • 원인
    Poor sensitivity and imprecision on advia centaur¿ systems; serum samples low bias; edta plasma samples low bias.
  • 조치
    Siemens sent an "URGENT FIELD SAFETY NOTICE" dated October 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructed customer to immediately discontinue the use of ADVIA Centaur Intact PTH (iPTH) assay kits that contain intact PTH (iPTH) reagent lot 138. It also recommended that for serum samples analyzed on the ADVIA Centaur CP system, the content of the Urgent Field Safety Notice be discussed with their laboratory director to determine the need to review previous test results, conduct patient follow up, and repeat testing for iPTH results that were less than the upper limit of the reference range, and had a companion calcium result that was elevated or at the upper limit of normal. Additionally, a Completion Notification form was attached for customers to complete and return. Customers should contact their local technical support provider for questions regarding this recall.

Device

ADVIA Centaur Intact PTH (iPTH) Assay
  • 모델명 / 제조번호(시리얼번호)
    500 Test Kits Kit Lot Number Expiry Date 17436138 15 January 2009 17601138 15 January 2009 19464138 15 January 2009 21240138 15 January 2009 23262138 15 January 2009 100 Test Kits Kit Lot Number Expiry Date 17435138 15 January 2009 18338138 15 January 2009 19929138 15 January 2009 20943138 15 January 2009 21835138 15 January 2009
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Chile, Columbia, Egypt, Finland, France, Hong Kong, India, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, South Korea, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Uruguay, and Venezuela.
  • 제품 설명
    ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) || Cat. Nos. || 100 Test kit 04385983 (129501) || 500 Test kit 06587575 (129502). || For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
  • 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