Events

Device Recall Wako Autokit Lp(a) Calibrator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wako Chemicals USA, 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
    61084
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1377-2012
  • 사례 시작날짜
    2012-01-30
  • 사례 출판 날짜
    2012-04-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107371
  • 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
    Lipoprotein, low-density, antigen, antiserum, control - Product Code DFC
  • 원인
    In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
  • 조치
    Wako Diagnostics notified its customers by telephone on January 26, 2012 and sent an Urgent Medical Device Recall letter dated January 30, 2012 to inform them of the product recall. The notifications identified the affected product, problem and actions to be taken. Consignees were requested to: 1) Complete and sign the attached Return Materials Authorization (RMA) Form to receive replacement material and 2) Package the recalled Product to be returned and send to the address listed on the RMA form. For questions call Technical Support Team at 1-877-714-1924.

Device

Device Recall Wako Autokit Lp(a) Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Lot No.: DJ427, Exp 08-31-12
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product had been sold to 2 customers in the US.
  • 제품 설명
    Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics || 1600 Bellwood Road Richmond, VA 23237*** || Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
  • Manufacturer
    Wako Chemicals USA, Inc.

Manufacturer

Wako Chemicals USA, Inc.
  • 제조사 주소
    Wako Chemicals USA, Inc., 1600 Bellwood Rd, Richmond VA 23237-1326
  • 제조사 모회사 (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA