Device Recall COULTER ACT 5diff Autoloader Hematology Analyzer 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
    58173
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1979-2011
  • 사례 시작날짜
    2011-02-23
  • 사례 출판 날짜
    2011-04-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    The recall was initiated because beckman coulter identified a problem with occasional unexpectedly high results for rbc, hct, plt and mpv without instrument generated messages, for the first run of a capped patient sample. upon repeat analysis the results are correct. patients could be affected as described below: (1) false high rbc and hct may result in a delay of treatment, or the delivery of.
  • 조치
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated February 23, 2011 with an enclosed customer response form to all customers who have the affected instruments via US Postal Service (in US). The letter described the product, problem and actions to be taken. The customers were instructed not to analyze specimens using the Autoloader. Instead, analyze their samples uncapped (open vial) using the Manual (Stat) Mode. The end of this notice includes a Quick Reference for Running Manual Samples. For more detailed instructions, please refer to your instrument's Instructions for Use (IFU), part number 624026, Section 8.4 Running Manual (Stat) Samples. An electronic version of the IFU can be found in the instrument's On-Line Help screen as well as the Beckman Coulter web site. For inconsistent data during patient's follow-up, please consider unusual/unanticipated high or elevated platelet levels as possible falsely elevated results due to this failure. An appropriate action for the need to look-back at previous results is at the discretion of the Laboratory Director, given the fact that laboratories have a variety of measures that are employed to ensure the validity of the results. Some of these provisions include delta checks, laboratory protocols for validating results and interaction with physicians. Additionally, the customers were also requested to complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM within ten (10) days via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015, or email to: Regulatory.notifications@beckmancoulter.com. For any questions concerning this notice, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers(s): All Serial Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Angola Mexico Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kong, India, Italy, Mexico, Netherlands, New Zealand, Nigeria, Palestinian, Puerto Rico, Romania, Russian Federation,Saudi Arabia, Slovenia, South Africa, Spain, Switzerland,Taiwan, Tanzania, and Turkey.
  • 제품 설명
    COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial || Numbers(s): All Serial Numbers || The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).
  • Manufacturer

Manufacturer

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