Events

Device Recall G7 Variant Elution Buffer HiS No. 1 (M) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tosoh Bioscience, 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
    71493
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2066-2015
  • 사례 시작날짜
    2015-02-10
  • 사례 출판 날짜
    2015-07-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137951
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • 원인
    The g7 variant elution buffer his no. 1 (m) is incorrectly labeled with an expiration date of october 2015. the correct expiration date is october 2014.
  • 조치
    Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764.

Device

Device Recall G7 Variant Elution Buffer HiS No. 1 (M)
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Us Nationwide Distribution in the state ID including PR.
  • 제품 설명
    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. || Product Usage: || G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
  • Manufacturer
    Tosoh Bioscience, Inc.

Manufacturer

Tosoh Bioscience, Inc.
  • 제조사 주소
    Tosoh Bioscience, Inc., 6000 Shoreline Ct Ste 101, South San Francisco CA 94080-7606
  • 제조사 모회사 (2017)
    Tosoh Corp.
  • Source
    USFDA