Events

Device Recall IMMAGE Immunochemistry Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    57750
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2045-2011
  • 사례 시작날짜
    2010-08-24
  • 사례 출판 날짜
    2011-04-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97319
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    Reagent, general purpose - Product Code LDT
  • 원인
    The recall was initiated because beckman coulter has confirmed an immage¿ systems wash solution lot 71744 was manufactured by a beckman european facility and not intended to be used in the u.S. however, this lot was inadvertently shipped to the u.S. and delivered to five customers.
  • 조치
    The firm, Beckman Coulter, contacted the customers who received the IMMAGE Immunochemistry Systems Wash Solution, lot #71744 by telephone. Beckman sent a follow-up "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 25, 2010, to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of Immage¿ Immunochemistry Systems Wash Solution lot 71744; return the material to Beckman Coulter's Chino warehouse: Beckman Coulter Inc., 15989 Cypress Ave, Chino, CA 91710, Phone: 909-597-3967; package the material the way it arrived and use Beckmans internal Fedex account to ship the material; complete and return an enclosed FAX BACK RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulator Affairs, 250 S. Kraemer Blvd, Brea, California 92821, Mail code E2.Se.08; share this information with laboratory staff; retain the notification as part of their Quality System documentation, and provide a copy of the letter if they forwarded the affected products. If you have any questions regarding this letter, please call Beckmans Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada.

Device

Device Recall IMMAGE Immunochemistry Systems
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 71744
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 유통
    Nationwide distribution: USA including states of : AL, CA, MI and IN.
  • 제품 설명
    IMMAGE¿ Immunochemistry Systems Wash Solution Part Number: 447060 || The IMMAGE¿ Immunochemistry Systems Wash Solution is intended for use with IMMAGE¿ Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE¿ Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA