Events

Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    60982
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1043-2012
  • 사례 시작날짜
    2011-12-19
  • 사례 출판 날짜
    2012-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106986
  • 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, time, partial thromboplastin - Product Code GGW
  • 원인
    The listed lots of dade(r) actin(r) fsl reagent show an increase in heparin sensitivity over the shelf life which is demonstrated by testing with dade(r) citrol(r) heparin control, low and high.
  • 조치
    Siemens sent an Urgent Field Safety Notice letter dated December 2011 to all customers of the affected lots. The letter identified the product, description of problem, and actions to be taken by the user. Dade¿ Actin¿ FSL customers were instructed to exercise one of two options: 1) If customers would like to continue working with their Dade(R) Actin FSL reagent lot (if one of the impacted lots) they must verify on a regular basis (monthly) that their therapeutic range is still valid, e.g. by using a Heparin containing control. In the case that it is not valid, they are to adjust their existing therapeutic range or establish a new one. 2) If customers decide not to continue working with the Dade(R) Actin(R) reagent lot (if one of the impacted lots) they are to contact their Siemens representative at 1-800-242-3233, option 5, for a replacement lot. Once they have established a new normal, therapeutic, and quality control ranges, they are to discard the remainder of the old lot. Customers were advised to complete the response form included to confirm receipt of Safety Notice and fax back to (302) 631-8467. If you have any questions or concerns, please contact the Technical Solutions Center at 1-800-242-3233, option 1.

Device

Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent
  • 모델명 / 제조번호(시리얼번호)
    Catalog number B4219-1J, lot numbers 537360, 537374 and 547301; catalog number B4219-1, lot numbers 537360A, 537366, 537374A, 547301A, and 547306; catalog number B4219-2J, lot numbers 534362 and 537365; and catalog number B4219-2, lot numbers 537362A and 537365A.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, Oman, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.
  • 제품 설명
    Dade(R) Actin(R) FSL Activated PTT Reagent || Product Usage: || Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA