Events

Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode 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
    56584
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1075-2013
  • 사례 시작날짜
    2010-08-18
  • 사례 출판 날짜
    2013-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94017
  • 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
    Hemoglobin a2 quantitation - Product Code JPD
  • 원인
    The beta-thalessemia mode of the g7 analyzer-beta thalassemia mode is an automated high performance liquid chromatography (hplc) system that separates and reports hbf and hba2 quantitative percentages in whole blood. the firm received complaints that the a2 peak could not be detected with the g7 beta-thalessemia columns.
  • 조치
    Please be aware that this is not a new recall. The firm has taken action. The firm stated that they have notified consignees via mail, with the list of notified customers maintained by the Regulatory Affairs/Quality Assurance department. The firm stated that they have notified distributors in the same way that they have notified other consignees, with a required confirmation to the firm of corrective actions.

Device

Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode
  • 모델명 / 제조번호(시리얼번호)
    11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.
  • 제품 설명
    G7 HPLC. || Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • 제조사 주소
    Tosoh Bioscience Inc, 3600 Gantz Road, Grove City OH 43123
  • Source
    USFDA