Events

BenchMark Automated Slide Stainer series 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Roche Diagnostics Ltd 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
    Safety alert / Field Safety Notice
  • 날짜
    2018-09-13
  • 사례 출판 날짜
    2018-09-13
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/benchmark-automated-slide-stainer-series-flo-lok-iii-reagent-dispenser-issue-for-ihc-and-ish-kits-including-inform-hpv-iii-family-16-probe-b-mda-2018-029
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
    MHRA issued a Medical Device Alert in February 2018 alerting users to reagent dispenser issues which could lead to weak or absent staining of tissue samples.The investigation identified the root cause was due to an inadequate application of oil in the manufacturing process. This has now been corrected.These devices are used to detect markers in a range of pathological conditions including those associated with cancer (e.g. HPV, HER2, ER/PR, ALK and PD-L1).As a consequence, there is a risk of false negative results (e.g. with all companion diagnostics such as HER2 tests) affecting clinical decisions for patients, due to commence treatment.
  • 원인
    Roche (ventana medical systems) has released an expansion of products affected by the reagent dispenser issues causing weak staining and the potential for false negative results and misdiagnosis.
  • 조치
    Ensure all relevant members of staff have received the Field Safety Notice and the actions required are taken. For users who have the affected INFORM HPV III kit (lot Y19417): No replacement kits are currently available Clinical testing can continue, but only with same slide controls. Contact the manufacturer to discuss the best alternative or send testing to another laboratory Ensure all remaining listed products are not used for clinical testing, replacement kits are now available from the manufacturer. The use of appropriate same slide controls is highly recommended as it helps ensure the efficacy of all IHC and ISH assays carried out on every slide on automated instruments. Users who have not used same slide controls should consider a review of previous test results obtained using the affected lots. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

BenchMark Automated Slide Stainer series
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    In addition to the Field Safety Notice which details affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.Product name Expanded Affected Lots Previously Communicated Lots OptiView DAB IHC Detection Kit Y24225, Y25760, E00119 Y19271, Y11625, Y15571 ULTRAVIEW UNIVERSAL DAB DETECTION KIT Y22147, Y25695 Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069 iView DAB Detection Kit Y24245 Y11834 ultraView SISH Detection Kit None Y15133 OptiView Amplification Kit None Y15435, Y19322, Y22447 OptiView Amplification Kit (250 Test) Y26282 Y19318 ultraView SISH DNP Detection Kit Y26299 Y17990 Hematoxylin II None Y10759, Y13938, Y17402, Y17403, Y21312 ISH iVIEW Blue Plus Detection Kit Y15410, Y24365 N/A ANTI-PAN KERATIN Primary Antibody, 25mL Y21610 N/A ultraView Universal Alkaline Phosphatase Red Detection Kit Y15071, Y18053, Y22469 N/A ISH Protease 3 Y13927, Y18872, Y22569, Y25883 N/A CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody Y12992, Y18852, Y23051 N/A CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody Y18586, Y24472 N/A VENTANA ISH iView Blue Detection Kit Y15105, Y22455 N/A INFORM HPV III Family 16 Probe (B) Y19417 N/A VENTANA anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody Y24119 N/A CINtec p16 Histology (250) CE Y16507, Y23040 N/A
  • Manufacturer
    Roche Diagnostics Ltd

Manufacturer

Roche Diagnostics Ltd
  • 제조사 주소
    Roche Diagnostics Ltd Charles Avenue Burgess Hill West Sussex RH15 9RY Registration Number: 571546Technical support helpline: 0808 100 1920Email: emea.tcceurope@roche.com
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • Source
    MHRA