Events

RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific Australia Pty Ltd 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-2015-RN-00063-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00063-1
  • 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
    Iris international (the manufacturer) has received reports of uncontained debris (part fragments) as a result of rotor breakage and lid failures on similar centrifuge models which use the rt12 rotor and shield. a shield was implemented on similar models and this notification is to inform ssmp users that the shield must be used when operating the centrifuge. there have been no reports of the statspin mp centrifuge failing to contain debris when users operate statspin mp centrifuges according to the statspin mp operator’s manual (doc # 55-001806-001) and rt12 tube rotor instructions (doc # 54-006155-001).
  • 조치
    ThermoFisher is providing additional maintainance instructions and updated operators manual. The information included is intended to supplement the current SSMP Operator Manual.

Device

RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)
  • 모델명 / 제조번호(시리얼번호)
    RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)RT12 Tube Rotor-Kit (RT12) Catalogue Number: RT12-KIT (REF x00-006152-001), Product Labeling: 54-006155-001StatSpin MP Centrifuge Catalogue Number: SSMP (REF x00-004998-001), Product Labeling: 55-001806-001HAll Serial Numbers
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd