Events

Device Recall LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Magellan Diagnostics, 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
    77695
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3035-2017
  • 사례 시작날짜
    2016-01-20
  • 사례 출판 날짜
    2017-08-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-02-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157541
  • 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
    Lead, atomic absorption - Product Code DOF
  • 원인
    Leadcare ii test kits controls out of range.
  • 조치
    Magellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix..

Device

Device Recall LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls
  • 모델명 / 제조번호(시리얼번호)
    Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
  • 제품 설명
    LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls || Product Usage: || IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
  • Manufacturer
    Magellan Diagnostics, Inc.

Manufacturer

Magellan Diagnostics, Inc.
  • 제조사 주소
    Magellan Diagnostics, Inc., 101 Billerica Ave Bldg 4, North Billerica MA 01862-1271
  • 제조사 모회사 (2017)
    Meridian Bioscience, Inc.
  • Source
    USFDA