Events

Device Recall LeadCare II Blood Lead Analyzer 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
    79279
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1295-2018
  • 사례 시작날짜
    2018-01-09
  • 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=161821
  • 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
    The incorrect placement of aa batteries into certain leadcare ii blood lead analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
  • 조치
    An Urgent Medical Device Correction letter, dated January 9, 2018, was sent to customers. The letter identified the affected device and provided a description of the issue. If two of the four AA batteries are inserted incorrectly, the batteries may overheat, causing a minor burn if the user opens the battery compartment and tries to remove the hot batteries. Customers are to follow the steps outlined in the letter, including placing the enclosed label on the upper back panel of the analyzer to remind users who are changing batteries of the importance of correct placement. Proper battery placement should be provided in annual training. Customers are to complete and return the acknowledgement card. Please direct any questions to 800-275-0102 or LeadCareSupport@magellandx.com.

Device

Device Recall LeadCare II Blood Lead Analyzer
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and  70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    LeadCare II Blood Lead Analyzer || Part Numbers: 70-6760, 70-6529-R, 70-6760-P, || 70-6760-R. || Intended for in vitro (external) use only.
  • 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