Events

DHEA RIA Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    57968
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2882-2011
  • 사례 시작날짜
    2010-09-09
  • 사례 출판 날짜
    2011-07-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97871
  • 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, dehydroepiandrosterone (free and sulfate) - Product Code JKC
  • 원인
    The recall was initiated because beckman coulter has confirmed customer reports that dhea measurements using dhea ria (ref dsl-8900) kit lots identified may overstate actual dhea levels in patient samples.
  • 조치
    Beckman Coulter sent an "URGENT: PRODUCT CORRECTION ACTION" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol, 17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was enclosed for customers to complete and return. Contact the Beckman Coulter Technical Support Center at 1-800-854-3633 in the United States, or their local Beckman Coulter Representative for questions regarding this notification.

Device

DHEA RIA Reagent
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 991112, 991346, 991584, 991857, 992115, 992359, 992458, 992854 were manufactured at: Beckman Coulter, Diagnostics Systems Laboratories, a Beckman Coulter Company, 445 West Medical Center Blvd, Webster, Texas 77598.  Lot numbers: 100115A, 100205A, 100205RA, 100226A, 100226RA, 100319A, 100319RA, 100409A, 100409RA, 100430A, 100430RA, 100521A, 100611A, 100611RA, 100702A, 100723A, 100723B, 100723RA, 100813A, 100813RB, 100813C were manufactured at: Immunotech, Prague, a Beckman Coulter Company, Radiova 1, Praha, 10227, Czech Republic.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
  • 제품 설명
    DHEA RIA Reagent || The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA