Events

UniCel DxC and Synchron LX Clinical 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
    59562
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0452-2012
  • 사례 시작날짜
    2010-09-02
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103085
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    The recall was initiated because beckman coulter has confirmed that the modular chemistry (mc) and cartridge chemistry (cc) 100 ul sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. excessive wear of the 100 ul sample syringe barrel and plunger could lead to leaking and may affect results.
  • 조치
    Beckman Coulter sent an URGENT: Product Corrective Action letter to all affected customers. The letter provided customers with an explanation of the problem identified and actions to be taken. The letter instructs customers to share this information with their laboratory staff and retain a copy as part of their laboratory Quality System documentation. In addition, the letter states that if the affected product was further distributed to provide a copy of the letter to them. Customers were also asked to complete and return the enclosed Response Form. For any questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.

Device

UniCel DxC and Synchron LX Clinical Systems
  • 모델명 / 제조번호(시리얼번호)
    Lot/Serial Numbers: All
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the country of Canada.
  • 제품 설명
    UniCel DxC and Synchron LX Clinical Systems 100 ¿L Sample Syringe, 100UL-PKGD, Part Number 474171 || Product Usage: The UniCel DxC and LX Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA