Events

Device Recall IMMULITE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics 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
    65609
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2047-2013
  • 사례 시작날짜
    2013-06-26
  • 사례 출판 날짜
    2013-08-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119702
  • 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 MFT
  • 원인
    Customers complained of a positive bias in patient results on the immulite/ immulite 1000 and the immulite 2000/ 2000 xpi psa assay when compared against the immulite /immulite 1000 3rd generation psa assay. siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the who 96/670 with the immmulite systems psa assay. this positive bias is observed in patient values and the siemens tumor marker controls (tmco). other commercially available controls may show this bias.
  • 조치
    Seimens sent an Urgent Medical Device Recall Letters to US consignees via FedEx and an Urgent Field Safety Notices were sent to the foreign consignees starting on June 26, 2013. In addition, Support Bulletins were distributed to Siemens Healthcare Diagnostics service personnel describing the issue and instructing them how to deal with customer questions. Customers were informed to discontinue use, discard the kits remaining in inventory and there are no replacement PSA kits available at this time. Siemens is instructing customers to contact their local Siemens representative for assistance with determining appropriate PSA testing solutions for your laboratory.

Device

Device Recall IMMULITE
  • 모델명 / 제조번호(시리얼번호)
    Product Code/Lot # LKPS1 424, Expiration Date 2013-08-31;  Product Code/Lot # LKPS1 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS1 426, Expiration Date 2013-10-31;  Product Code/Lot # LKPS5 424, Expiration Date 2013-08-31;  Product Code/Lot # LKPS5 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS5 426, Expiration Date 2013-10-31; Product Code/Lot # LKPTS1(D) D0104, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS2 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS6 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS6 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS2(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D109, Expiration Date 2013-10-31;  Product Code/Lot # L2KPTS6(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS6(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS6(D) D109, Expiration Date 2013-10-31.
  • 유통
    Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: Albania, Afghanistan, Algeria, Argentina, Austria, Bangladesh, Belgium, Bolivia, Bosnia- Herzegovinia, Brazil, Bulgaria, Camaroon, Canada, Canary Islands, Chile, China, Colombia, Coast Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, South Africa, Rep. of Korea (S), Sweden, Switzerland, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, Uruguay, White Russia, Venezuela, and Vietnam.
  • 제품 설명
    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. || Product Usage: || 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. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • 제조사 주소
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA