Events

Device Recall Randox Liquid Assayed Specific Protein Control Level 2 (SP Control 2) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Randox Laboratories Ltd. 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
    80211
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2279-2018
  • 사례 시작날짜
    2018-05-22
  • 사례 출판 날짜
    2018-06-13
  • 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=164878
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • 원인
    The recalling firm has confirmed that free kappa light chains in liquid assayed specific protein controls increase over the shelf life of the product. this may lead to a delay in reporting free kappa light chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lambda chains.
  • 조치
    On May 22, 2018, Randox issued an Urgent Field Safety Notice to affected distributors along with an Important Notice and updated IFU. The letter advised customers of the product issue. It further instructed distributors to do the following: 1. Discuss the contents of the notice with your Medical Director. 2. Place a copy of the important notice and updated IFU into any remaining stock. 3. Complete and return the vigilance response section of this form to technical.services@randox.com within five working days. If you have any questions after reviewing this information, you may contact the firm at technical.services@randox.com.

Device

Device Recall Randox Liquid Assayed Specific Protein Control Level 2 (SP Control 2)
  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed to accounts in CA, IN, KS, ME, and WV, and PR. Foreign distribution to Australia, Bangladesh, Belarus, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Cyprus, Denmark, Dutch Caribbean, Ecuador, Egypt, El Salvador, Ethiopia, Falkland Islands, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Italy, Jordan, Kenya, Saudi Arabia, Korea, Kuwait, Latvia, Lebanon, Peru, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Morocco, Myanmar, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Oman, Thailand, Netherlands, Turkey, United Arab Emirates, United Kingdom, Ukraine, Vietnam, and Zimbabwe.
  • 제품 설명
    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
  • Manufacturer
    Randox Laboratories Ltd.

Manufacturer

Randox Laboratories Ltd.
  • 제조사 주소
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • 제조사 모회사 (2017)
    Randox Holdings Limited
  • Source
    USFDA