Events

Device Recall MESOMARK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fujirebio 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
    56427
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1606-2011
  • 사례 시작날짜
    2010-07-29
  • 사례 출판 날짜
    2011-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93728
  • 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
    Cancer monitoring test system, soluble mesothelinrelated peptides, epithelioid/biphasic mesothelioma - Product Code OAW
  • 원인
    Presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.
  • 조치
    Notification dated 7/7/10 was sent to the customer via e-mail and FedEx Priority Overnight. FUJIREBIO Diagnostics, Inc. sent an URGENT PRODUCT CORRECTION NOTIIFICATION letter dated July 7, 2010, to all affected customers via e-mail and FedEx Priority Overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue using MESOMARK kit. Lot 57K04510 and discard any remaining inventory. Complete and return the attached Confirmation of Receipt form upon receipt of this notification, no later than July 30, 2010. Notify your ordering physician or health care provider as appropriate. For questions regarding this recall call 877-861-7246 or 610-240-3800.

Device

Device Recall MESOMARK
  • 모델명 / 제조번호(시리얼번호)
    Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    HDE
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including UT
  • 제품 설명
    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. || MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.
  • Manufacturer
    Fujirebio Diagnostics, Inc.

Manufacturer

Fujirebio Diagnostics, Inc.
  • 제조사 주소
    Fujirebio Diagnostics, Inc., 201 Great Valley Pkwy, Malvern PA 19355-1308
  • 제조사 모회사 (2017)
    Miraca Holdings, Inc.
  • Source
    USFDA