Events

Device Recall IMMULITE/IMMULITE 2000 PSA Assay 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
    75798
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0885-2017
  • 사례 시작날짜
    2016-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151296
  • 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
    Total,prostate specific antigen(noncomplexed&complexed;) for detection of prostate cancer - Product Code MTF
  • 원인
    Siemens healthcare diagnostics confirmed that the immulite 2000/ immulite 2000 xpi systems psa assays are not meeting the current high-dose hook effect expectation in the instructions for use.
  • 조치
    The firm, Siemens, sent an "Urgent Medical Device Correction Letter" (IMC 17-07.A.US, dated 11/2016) was sent via FedEx on 11/18/2016 to the US customers and an "Urgent Field Safety Notice" dated 11/2016 to customers outside the US (distribution is determined at the country level). The letter/notice described the product, problem and actions to be taken. Additionally, Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers were instructed to review letter with your medical doctor; review products and follow instructions; complete and return the attached Field Correction Effectiveness Check Form within 30 days by fax to Customer Care Center at (312) 275-7795; retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall IMMULITE/IMMULITE 2000 PSA Assay
  • 모델명 / 제조번호(시리얼번호)
    All lots L2KPS2/L2KPS6 - Lots 408, 409, 410 L2KPTS2/L2KPTS6 - Lots D112, D123, D124
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • 제품 설명
    IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK || For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA