Device Recall Pacific Hemostasis Fibrinogen Degradation Products 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fisher 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
    77340
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2762-2017
  • 사례 시작날짜
    2017-05-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-06-29
  • 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
    System, fibrinogen determination - Product Code KQJ
  • 원인
    An issue was discovered with the pacific hemostasis fibrinogen degradation products (fdp) kit, list number 100650, lot 948546 and fdp latex reagent, list 100651, lot 890199. while the kit performs accurately at fdp concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when fdp levels are less than 20 ¿g/ml. this reduction in sensitivity has been tied to fdp latex reagent lot 890199 and may result in false negatives.
  • 조치
    ThermoFisher Scientific sent an MEDICAL DEVICE RECALL Letter dated May 16, 2017, to all affected customers and response forms were sent to customers on May 19, 2017. Customers are informed of the recall and potential health risks and instructed to review their test results. Review your inventory and any product on hand is to be discarded. --- The firm ceased distribution of the lots and began its investigation. The held product will ultimately be destroyed. Level A effectiveness checks will be conducted to the consignees and repeated attempts will be made to non-responding customers. The firm will track all mailed, emailed and faxed return forms for the duration of the recall. For further questions, please call (540) 869-8188.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 948546, Exp. 9/30/2017
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) including Puerto Rico, and Internationally to Colombia
  • 제품 설명
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Fisher Diagnostics, 8365 Valley Pike, Middletown VA 22645-1905
  • Source
    USFDA