Events

Device Recall Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader 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
    57757
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1731-2011
  • 사례 시작날짜
    2010-12-14
  • 사례 출판 날짜
    2011-03-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97338
  • 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
    Differential Cell Counter - Product Code GKZ
  • 원인
    The recall was initiated because beckman coulter has confirmed the coulter maxm, maxm al, hmx and hmx al analyzers omit the tilde (~) character when the tilde is used as part of the sample 10 within a barcode label scanned by the primary mode barcode reader. there is a potential for specimen or patient misidentification to occur.
  • 조치
    The recall communication was initiated on 12/14/2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER HmX Hematology Analyzer, COULTER HmX Hematology Analyzer with Autoloader, COULTER MAXM Analyzer, COULTER MAXM Hematology Analyzer with Autoloader. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed not to use the tilde (~) character in Specimen or Patient identifiers. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Device

Device Recall Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Algeria, Andorra, Antigua and Barbuda, Australia, Austria, Bahrain, Bangladesh, Bermuda, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Canada, Cayman Islands, China, Congo, Cote d'Ivoire, Croatia, Czech Republic, Djibouti, Egypt, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Libyan Arab, Jamahiriya, Lithuania, Macao, Malawi, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sudan, Swaziland, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands, Yemen, and Zambia.
  • 제품 설명
    Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. || Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, and 6706000. || Quantitative, automated, differential cell counters for in vitro diagnostic use.
  • 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