QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cellestis 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
    64228
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0889-2013
  • 사례 출판 날짜
    2013-02-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-04-25
  • 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
    Test, immunity, cell mediated, mycobacterium tuberculosis - Product Code NCD
  • 원인
    Cellestis is recalling quantiferon¿¿ - tb gold tb blood collection tubes and ha tb blood collection tubes due to potential contamination.
  • 조치
    Cellestis, inc., sent a "Notification of market withdrawal of QuantiFERON¿" letter dated September 27, 2012 to its domestic and international customers. The letter described the product, problem and actions to be taken. The customers were informed to discontinue use of these products and any product sequestered such that it cannot be used or distributed. Cellestis will provide replacement materials, if and when a retest is required. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative at +613 8527 3500 or 661-775-7480 should you have any questions or concerns.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.
  • 제품 설명
    Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. || Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cellestis Inc, 28358 Constellation Rd Ste 698, Santa Clarita CA 91355-5044
  • 제조사 모회사 (2017)
  • Source
    USFDA