Events

Device Recall Instrumentation Labs Test Plasminogen 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Instrumentation Laboratory Co. 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
    72972
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0736-2016
  • 사례 시작날짜
    2015-12-18
  • 사례 출판 날짜
    2016-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142610
  • 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, qualitative and quantitative factor deficiency - Product Code GGP
  • 원인
    This lot is not meeting labeled on-board instrument stability claims of 5 days.
  • 조치
    Instrumentation Laboratory Co. sent an " Urgent Medical Device Removal" letter dated December 2015, was sent on December 18, 2015. via USPS to US and Canadian customers. The notification requires US and Canadian customers to respond using a Mandatory Response Tracking Form. A Field Safety Notice was e-mailed on December 18, 2015, to the affected IL affiliates, notifying them of the product lot removal due to a stability issue and requesting them to translate the Field Safety Notice, to notify their Competent Authorities and to provide the notification to their affected customer base and secondary distributors. For further questions, please call 1(800) 955-9525.

Device

Device Recall Instrumentation Labs Test Plasminogen
  • 모델명 / 제조번호(시리얼번호)
    Lot No. N0455811, Expiration Date 03/31/2017
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.
  • 제품 설명
    HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • 제조사 주소
    Instrumentation Laboratory Co., 180 Hartwell Rd, Bedford MA 01730-2443
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA