Events

Device Recall Quantikine IVD Human sTfR Immunoassay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 R & D Systems, 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
    75016
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2887-2016
  • 사례 시작날짜
    2016-08-24
  • 사례 출판 날짜
    2016-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149122
  • 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
    Immunochemical, Transferrin - Product Code JNM
  • 원인
    R&d; systems, inc. received two customer complaints that results of the controls provided with the quantikine¿ ivd¿ human stfr immunoassay kit were out of the range high. internal testing within r&d; systems confirmed a problem with control results being out of range high.
  • 조치
    Consignees were sent via US mail on 8/24/2016 a R&D; systems "Urgent Medical Device Recall" letter dated August 23, 2016. The letter described the problem and the product involved in the recall. Advised consignees to stop using the kits and to discard all unused kits and complete and return the enclosed Acknowledgement and Receipt Form. For questions contact Bio-Technes Technical Service Department at 1-612-379-2956 or techserv@bio-techne.com.

Device

Device Recall Quantikine IVD Human sTfR Immunoassay
  • 모델명 / 제조번호(시리얼번호)
    331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA. OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.
  • 제품 설명
    R&D; Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
  • Manufacturer
    R & D Systems, Inc.

Manufacturer

R & D Systems, Inc.
  • 제조사 주소
    R & D Systems, Inc., 614 McKinley Pl NE, Minneapolis MN 55413-2610
  • 제조사 모회사 (2017)
    R & D Systems Inc
  • Source
    USFDA