Events

Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Health Products, 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
    32890
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0624-06
  • 사례 시작날짜
    2005-03-23
  • 사례 출판 날짜
    2006-03-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41034
  • 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
    Fluroesence Polorization Immunoassay For Cyclosporine - Product Code MGU
  • 원인
    Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. an important product information letter with technical information regarding the whole blood calibrators and controls, implementing new internal reference standards was issued.
  • 조치
    Abbott has recently implemented new internal reference standards for TDx/TDxFLx Cyclosporine monoclonal Whole Blood Calibrators and Controls. A change in performance is associated with the use of calibrator lots 1829Q100 and higher and control lots 18230Q100 and higher, which are the first lots manufactured using the new internal reference standards. The specific performance changes are identified in the letter, dated March 23, 2005, as compared to current product using the previous standards (calibrators lot 05434Q100 and control lot 03071Q100).

Device

Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls
  • 모델명 / 제조번호(시리얼번호)
    Lot 18229Q100 (exp 8/26/2006) Lot 18230Q100 (exp 10/05/2006)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Puerto Rico, Hawaii, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Canada, Germany, Japan , Singapore, India, Taiwan, Thailand, Korea, Australia, Honduras, and Panama,
  • 제품 설명
    In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).
  • Manufacturer
    Abbott Health Products, Inc.

Manufacturer

Abbott Health Products, Inc.
  • 제조사 주소
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Cruze Davila, Barceloneta PR 00617
  • Source
    USFDA