Events

IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Siemens Healthcare Diagnostics GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-12-22
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • 데이터 추가 비고
  • 원인
    2000 xpi assays listed in table 1 are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results on the assays listed above. the instructions for use (ifu) currently do not list biotin as a potential interferant. concentrations of biotin above the concentration listed in table 2 can potentially result in interference greater than 10%, leading to either falsely elevated or falsely depressed results. .

Device

IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays
  • 모델명 / 제조번호(시리얼번호)
    3gAllergy™ Specific IgE Universal Kit IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 L2KUNJ6 10380875 10711939 Anti HBc IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 10381311 BR-MA (CA15-3) IMMULITE/IMMULITE 1000 LKBR1 10380948 BR-MA (CA15-3) IMMULITE 2000/IMMULITE 2000 XPi L2KBR2 10380983 CEA IMMULITE/IMMULITE 1000 LKCE1 10380945 CEA IMMULITE 2000/IMMULITE 2000 XPi L2KCE2 L2KCE6 10380994 10380995 CK-MB IMMULITE/IMMULITE 1000 LKMB1 10381016 CK-MB IMMULITE 2000/IMMULITE 2000 XPi L2KMB2 10381033 EPO IMMULITE/IMMULITE 1000 LKEPN1 10487627 EPO IMMULITE 2000/IMMULITE 2000 XPi L2KEPN2 L2KEPN6 10487628 10487629 SIEMENS Folic Acid IMMULITE 2000/IMMULITE 2000 XPi L2KFO2 L2KFO6 10380911 10380912 Gastrin IMMULITE/IMMULITE 1000 LKGA1 10380962 Gastrin IMMULITE 2000/IMMULITE 2000 XPi L2KGA2 10380979 OM-MA (CA125) IMMULITE/IMMULITE 1000 LKOP1 10380969 OM-MA (CA125) IMMULITE 2000/IMMULITE 2000 XPi L2KOP2 10380972 Thyroglobulin IMMULITE/IMMULITE 1000 LKTY1 10381644 Thyroglobulin IMMULITE 2000/IMMULITE 2000 XPi L2KTY2 10381648 Vitamin B12 IMMULITE/IMMULITE 1000 LKVB1 10380900 Reason for Correction Siemens Healthcare Diagnostics has confirmed through internal investigation that the IMMULITE ® /IMMULITE ® 1000/IMMULITE ® 2000/IMMULITE
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

Siemens Healthcare Diagnostics GmbH