Device Recall CoatACount TSH IRMA IKTS1 with calibrator TSI3X Lot 035 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics 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
    63852
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0646-2013
  • 사례 시작날짜
    2012-11-28
  • 사례 출판 날짜
    2013-01-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-10-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, thyroid-stimulating hormone - Product Code JLW
  • 원인
    The recall was initiated because siemens healthcare diagnostics confirmed an under-recovery of dose values with some vials of coat-a-consta (cac) irma tsh calibrators tsi4 (level b), tsi5 (level c), tsi6 (level d), tsi8 (level f), and tsi9 (level g) lot 035. the affected calibrator vials can be identified by a darker yellow color than normal. the tsi3 (level a), tsi7 (level e), and tsix (level h).
  • 조치
    Siemens sent an Urgent Medical Device Recall letter dated November 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, complete and return the Urgent Medical Device Recall Effectiveness Check form included with the letter by fax to 302-631-7597. Customers were also instructed to determine their replacements needed, and to forward the recall letter to whomever they may have distributed the affected product. For questions customers were instructed to contact their Siemens Technical Solutions Ceter or their local technical support representative. For questions regarding this recalla call 914-524-2955.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lots 969 and 970
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,
  • 제품 설명
    Immunoradiometric assay. || Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA