Events

Hologic ThinPrep 5000 Processor with Autloloader (Instrument Analyser) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Hologic 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
    20118
  • 사례 시작날짜
    2016-05-04
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • 원인
    In rare cases, it is possible, for the thinprep® 5000 processor with autoloader to misread the value encoded in the vial barcode label. this occurs when the barcode scanner decodes a value that meets all symbology rules and check-digit validation but is not the intended value encoded in the barcode and processes the vial using this identifier., in an autoloader configuration, if a misread occurs, the misread vial id value is transferred to the slide and a slide is produced with the incorrect identifier.
  • 조치
    Instructions for use to be updated

Device

Hologic ThinPrep 5000 Processor with Autloloader (Instrument Analyser)
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected:
  • Manufacturer
    Hologic Inc

Manufacturer

Hologic Inc