Events

Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measurement. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Clinical Diagnostic Systems 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
    79508
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1322-2018
  • 사례 시작날짜
    2018-01-11
  • 사례 출판 날짜
    2018-04-10
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162526
  • 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
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • 원인
    Vitros tsh reagent lots have been found to generate higher than expected calibrator level 2 signals on some customer systems. these calibrator level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the customer calibration curve between calibrator level 2 and calibrator level 3.
  • 조치
    Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.

Device

Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measu...
  • 모델명 / 제조번호(시리얼번호)
    Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
  • 제품 설명
    VITROS Immunodiagnostic Products TSH Reagent Pack
  • Manufacturer
    Clinical Diagnostic Systems

Manufacturer

Clinical Diagnostic Systems
  • 제조사 주소
    Clinical Diagnostic Systems, 601 Lee Rd Ny, Rochester NY 14652-0001
  • 제조사 모회사 (2017)
    Boule Diagnostics AB
  • Source
    USFDA