Events

Device Recall Multiphor" II Electrophoresis System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Perkinelmer Life Sciences, 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
    77267
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2685-2017
  • 사례 시작날짜
    2017-05-15
  • 사례 출판 날짜
    2017-05-22
  • 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=155585
  • 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
    Apparatus, electrophoresis, for clinical use - Product Code JJN
  • 원인
    Potential for electric shock in the case of a failure to install the grommets, supplied with the system.
  • 조치
    Perkin Elmer issued URGENT: Field Correction letter on 5/15/17 and accompanied with the GE HealthCare Important Product Information letter The notifications will be delivered to the end customer by email facilitated through PerkinElmer Technical Support group located in Akron Ohio. Technical Support will ensure the customers receive the both letters and understand the recommended actions. Accounts requested to complete the enclosed Response Form. Questions regarding the actions to be taken, as outlined in the GE HealthCare letter, should be directed via email to orderFI@ge.com or via phone (in the US) 011 44 800 515313, (in the UK) 0800 515 313, and (rest of world) +44-800 515 313.

Device

Device Recall Multiphor" II Electrophoresis System
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 1171221 1171231 1171232 1171234 1181923 1181925 1181928 1187499 1189475 1189484 1195060 1195074 1197741 1197743 1197752 1197753 1200106 1202993 1202994 1251991 1252000 1253298 1253301 1253307 1254797 1254798 1255972 1264957 1264960 1302820 1302823 1313213 1320921 1320925 1320927 1331757 1383503 1383506 1406432 1413361 1434395 1434396 1434399 1435683 1436876 1442735 1463140 1465792 1465793 1465794 1480331 1480829 1480834 1486179 1486180 1487157 1487158 1487159 1487160 1487161 1487162 1487182 1497464 1497490 1509220 1525734 1525737 1525739 1525741 1525744 1525745 1525748 1540014 1540016 1540018 1540019 1540020 1550838 1550839 1561681 1564304 1604476 1604481 1607341 1607345 1607346 1624871 1624873
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Multiphor II Electrophoresis System || GE HealthCare Product Number: 18-1018-06 || PerkinElmer Part Number: 2117-004 || Product Usage: || Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
  • Manufacturer
    Perkinelmer Life Sciences, Inc.

Manufacturer

Perkinelmer Life Sciences, Inc.
  • 제조사 주소
    Perkinelmer Life Sciences, Inc., 549 Albany St, Boston MA 02118-2512
  • 제조사 모회사 (2017)
    Perkin Elmer Inc.
  • Source
    USFDA