Events

Device Recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    64463
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1049-2013
  • 사례 시작날짜
    2013-02-22
  • 사례 출판 날짜
    2013-04-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116185
  • 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
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • 원인
    Siemens healthcare diagnostics has initiated a voluntary field action for dimension(r) phos flex(r) reagent due to reagent interaction causing falsely depressed creatinine results when ezcr is processed from open wells that are in close proximity to open wells of phos reagent.
  • 조치
    Siemens sent an Urgent Medical Device Correction letter dated February 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by Customer: 1. Customers with two or more Dimension systems should perform testing of PHOS and EZCR on separate Dimension systems. 2. Customers with only one Dimension system should discontinue use of either PHOS or EZCR on the Dimension system. Please contact your local sales representative to discuss alternate solutions that will best meet the needs of your laboratory. Please complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at (302) 631-8467, to indicate you have received the information. If you have any questions, please contact the Siemens Technical Solutions enter or your local Siemens technical support representative. We apologize for the disruption this situation will cause your laboratory. We are working diligently to resolve this issue with a permanent solution. .

Device

Device Recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • 제품 설명
    Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) || The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA