Events

Device Recall AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zeus Scientific, 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
    61646
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1500-2012
  • 사례 시작날짜
    2012-03-08
  • 사례 출판 날짜
    2012-05-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108635
  • 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
    Enzyme linked immunoabsorbent assay, mumps virus - Product Code LJY
  • 원인
    Select lots of athena multi-lyte mmv test system have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against mumps.
  • 조치
    The firm, Zeus Scientific, sent an "URGENT NOTICE; Voluntary Product Recall" letter dated March 8, 2012 their customers via Fed Ex. The letter described the product, problem and actions to be taken. The customers were instructed to remove and discard any remaining inventory of the listed product; if you are not the end-user and/or you have distributed these products to customers, notify them accordingly; and complete, sign and return the verification notice via fax to: 908-526-2058 or email a PDF to support@zeusscientific.com. If you have any questions, call 908-526-3744 or 800-286-2111.

Device

Device Recall AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G
  • 모델명 / 제조번호(시리얼번호)
    11120087 11120165  11110125 : (This is an amendment to add the additional lot 11110125 which was left off.. This amendment was made on 6/6/2012.)
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    AtheNA Multi-Lyte MMV Test System- A93111G || A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus.
  • Manufacturer
    Zeus Scientific, Inc.

Manufacturer

Zeus Scientific, Inc.
  • 제조사 주소
    Zeus Scientific, Inc., 200 Evans Way, Branchburg NJ 08876-3767
  • 제조사 모회사 (2017)
    Zeus Scientific, Inc.
  • Source
    USFDA