Device Recall Coulter Lyse S III diff Lytic 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
    58235
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2213-2011
  • 사례 시작날짜
    2010-12-28
  • 사례 출판 날짜
    2011-05-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-06-04
  • 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
    Red-Cell lysing products - Product Code GGK
  • 원인
    The recall was initiated by beckman coulter because the coulter lyse iii diff lytic reagent lot number 101554f was released for distribution to customers between november 17 and december 1, 2010 prior to completion of qc testing.
  • 조치
    Beckman Coulter sent a Product Corrective Action ( PCA) letter dated December 28, 2010, to all affected consignees with an attached PCA Response form via US Postal Service for US Customers) who purchased the Coulter Lyse S III diff Lytic Lot # 101554F. The letter provides customers with an explanation of the problem identified and an action to be taken. If customers currently had any of the lot mentioned above in their laboratory, they were asked to discontinue use and discard remaining product according to their laboratory chemical safety procedures. And to complete and return the enclosed response form within 10 days to acknowledge that they received this notice and are taking appropriate action. For the population at most risk, there is no serious consequences and only remote probability of injury and medically reversible consequences due by the small change for Hgb and WBC results. Consignees were also asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Technical questions regarding this Product Corrective Action were directed to Beckman Coulter Customer Service at( 800) -526-7694 in the United States and Canada.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 101554F
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distrubution-- USA ( nationwide) including states of : AL, AR, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, RI, SC, TN, TX, VA, WI, & WV and country of Canada.
  • 제품 설명
    COULTER LYSE S III diff Lytic Part Number: 8546796. || COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.
  • Manufacturer

Manufacturer

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