Events

Synchron Systems(s) Creatinine Reagent (CREm) 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
    56424
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2389-2010
  • 사례 시작날짜
    2010-08-02
  • 사례 출판 날짜
    2010-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93640
  • 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
    Alkaline picrate, colorimetry, creatinine - Product Code CGX
  • 원인
    The recall was initiated after beckman coulter confirmed reports that black / brown particulates were observed in some bottles of the creatinine alkaline buffer (buffer lot m911427 and m911518) in modular creatinine (crem) reagent kit lots m911428 and m911519. beckman coulter have had reports of erroneous results when using the lots of creatinine alkaline buffer listed above. single creatinine d.
  • 조치
    The firm, Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 3, 2010, to all customers. The letter describes the product, problem, and action to be taken by customer. The customers were instructed to: (1) Please discontinue use of Creatinine (CREm) reagent kit lots M911428 and M911519 and discard appropriately. (2) Please contact Beckman Coulter at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss CREm kit M911428 and M911519 replacement options. Outside the United States and Canada, please contact your local Beckman Coulter Representative. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. (4) Please share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, they were instructed to please contact Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.

Device

Synchron Systems(s) Creatinine Reagent (CREm)
  • 모델명 / 제조번호(시리얼번호)
    Lot Number(s): M911428 & M911519
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY and country of Canada
  • 제품 설명
    SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 || Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. || CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.
  • 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