Events

WIZARD2 Gamma Counters. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 PerkinElmer 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
    RC-2016-RN-00250-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00250-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    This is a follow up to a previous recall in 2015 (tga ref: rc-2015-rn-00417-1). it has been identified that the affected barcodes were distributed from february 2010, not june 2012 as originally understood. perkinelmer have become aware that the content of the second of the two #023 barcode id labels provided on each page of the barcode id label binder are incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. in the event measurement protocols have been programmed for both id #023 and #024, and the wizard2 gamma counter scans the affected barcode label, the protocol associated with barcode id #024 is executed. if the error is undetected, the wizard2 gamma counter may produce erroneous results.The issue will lead to a delay in reporting results due to the delay to resolve the issue and retest the samples or test new samples. dependent on individual patient clinical status an incorrect result may impact disease progression or renal function.
  • 조치
    Users are advised to ensure that they remove the barcode labels ID #023 from all barcode label binders in their possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided to affected customers. This action has been closed-out on 18/05/2017.

Device

WIZARD2 Gamma Counters. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    WIZARD2 Gamma Counters. An in vitro diagnostic medical device (IVD)WIZARD2 1-detector, 550 samplesCatalogue Number: 2470-0010WIZARD2 2-detector, 550 Catalogue Number: 2470-0020WIZARD2 5-detector, 550 Catalogue Number: 2470-0050 WIZARD2 1-detector, 3",1000Catalogue Number: 2480-0010Multiple Serial Numbers affectedARTG Number: 209297
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer