Events

Device Recall Active Cortisol EIA 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
    55227
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2761-2011
  • 사례 시작날짜
    2009-07-20
  • 사례 출판 날짜
    2011-07-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90374
  • 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
    Radioimmunoassay, cortisol - Product Code CGR
  • 원인
    The recall was initiated because beckman coulter has confirmed that the listed lot numbers of active control elisa reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. beckman coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica.
  • 조치
    Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970. Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number listed below. Consignees were asked to share this information with laboratory staff and retain the PCA letter for their Quality System documentation, and complete and return the enclosed Response Form within 10 days so that the firm can be assured that they received the notification. Questions regarding this notification were directed to the DSL Technical Support Center at 1-800-231-7970 in the United State and Canada, or their local Beckman Coulter Representative.

Device

Device Recall Active Cortisol EIA
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers Epiration Dates 04195 8/15/2006 04195A 10/18/2006 04195B 1/26/2006 04195D 8/15/2006 04195E 10/18/2006 04195F 10/18/2006 09266A 01/31/2006 09266 10/17/2007 04126A 10/11/2007 04126 7/28/2007 03066A 09/05/2007 03066 09/05/2007 01036 07/02/2007 716217 06/06/2008 716218 07/29/2008 800408 05/07/2009 800409 05/07/2009 800410 05/07/2009 890829 09/03/2009 990168 09/03/2009
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Canada.
  • 제품 설명
    Active Cortisol EIA, 96 Wells, DSL-10-2000 || The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended 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