Events

Device Recall Diagnostica Stago Inc. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Diagnostica Stago, 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
    64320
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0951-2013
  • 사례 시작날짜
    2013-01-28
  • 사례 출판 날짜
    2013-03-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115819
  • 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
    Plasma, coagulation factor deficient - Product Code GJT
  • 원인
    Diagnostica stago has confirmed that sometimes the delta od measured can be changed leading to a lowered percentage result.
  • 조치
    Diagnostica Stago Inc. sent e-mail notifications on 1/28/2013 to all consignees (laboratory supervisor). The written field safety notice, entitled Important Field Safety Notice, with its response form was attached. The letter identified the affected product and gave a description of the defect. Customers were asked to confirm all the results obtained in the abnormal range by either of the two methods provided. Users are to complete and return the enclosed response form as soon as possible to the Stago Hotline via fax, 973-644-9348. Questions should be directed to the Stago Hotline at 800-725-0607.

Device

Device Recall Diagnostica Stago Inc.
  • 모델명 / 제조번호(시리얼번호)
    Lot/Unit Numbers : Combination of All STA-R¿/ STA-R EVOLUTION¿ and lots of STA¿ - LIATEST¿ VWF: AG are involved.    Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and Canada.
  • 제품 설명
    Vial Label: || 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago || 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago || 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago || Model, catalogue, number 00518 - 58978 - 58979 || Kit Label: || LIATEST VWF:Ag || DIAGNOSTICA STAGO S.A.S. || 92600 Asni¿res sur Seine (France) || Coagulation Assay
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

Diagnostica Stago, Inc.
  • 제조사 주소
    Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
  • Source
    USFDA