Events

uTASWako DCP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wako Life Sciences, 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
    65084
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1831-2013
  • 사례 시작날짜
    2013-04-30
  • 사례 출판 날짜
    2013-07-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117873
  • 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
    Albumin, antigen, antiserum, control - Product Code DCF
  • 원인
    Product fails to meet the accuracy at the low end of the measuring range.
  • 조치
    Wako Life Sciences, Inc. sent an email and issued a Recall Notice letter via FED EX on April 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue the use of these kits, fill out the attached RMA form, and return unused kits using Wako's FedEx account (provided on RMA form). Partially used reagent cartridges should be disposed of according to your local and state requirements. Wako Life Sciences will relplace your existing stock of uTASWako DCP kits with kits from a different log number that has been tested and has shown to not be affected. If you have any questions regarding the Recall, please submit your inquiries to liver@wakousa.com or call 443-535-0702.

Device

uTASWako DCP
  • 모델명 / 제조번호(시리얼번호)
    TG340, Exp. 11/30/13
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution to CA, GA, MN, NC, UT and the District of Columbia.
  • 제품 설명
    uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a || single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
  • Manufacturer
    Wako Life Sciences, Inc.

Manufacturer

Wako Life Sciences, Inc.
  • 제조사 주소
    Wako Life Sciences, Inc., 1025 Terra Bella Ave, Mountain View CA 94043-1829
  • 제조사 모회사 (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA