Events

Access and Access 2 Immunoassay System 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
    48186
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2384-2008
  • 사례 시작날짜
    2008-04-03
  • 사례 출판 날짜
    2008-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70962
  • 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
    Acid, folic, radioimmunoassay - Product Code CGN
  • 원인
    The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the access and access 2 immunoassay systems. premature failure of the waste pump tubing may negatively affect precision.
  • 조치
    A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Customer Response form was mailed on June 30, 2008 via US Postal mail to include all customers with the following products: UniCel Dxl 800 and DxC 880i Systems with pump manufacturing number (Mfg.) of 01-010341-1 and serial number (SN) 22454201 and above, and UniCel Dxl 600 Systems with a pump Mfg. No. A24468 and SN of 22965501. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump SN referenced. If you have questions, contact Customer Technical Support at 1-800-854-3633.

Device

Access and Access 2 Immunoassay System

Manufacturer

Beckman Coulter Inc
  • 제조사 주소
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA