SSP UNITRAY - HIGH RESOLUTION CLASS II 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 LIFE TECHNOLOGIES CORPORATION 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
    70949
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-09-04
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    On june 26 2014 one customer complaint was received for this issue (internal ref. # pr162312): a customer reported that a sample had discrepant results when using ssp unitray versus two other typing methods. ssp unitray typed the sample as dpb1*04:01dpb1*81:01. the correct assignment should be dpb1*04:01 dpb1*33:01. this is considered a mistype result.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 451616D (Lot serial: 009 1568516); Model Catalog: 451606D (Lot serial: 009 1568516); Model Catalog: 451606D (Lot serial: 008 1154360); Model Catalog: 451616D (Lot serial: 009 1464121); Model Catalog: 451606D (Lot serial: 009 1464121); Model Catalog: 451616D (Lot serial: 009 1415057); Model Catalog: 451606D (Lot serial: 009 1415057); Model Catalog: 451616D (Lot serial: 008 1289713); Model Catalog: 451606D (Lot serial: 008 1289713); Model Catalog: 451616D (Lot serial: 008 1220578); Model Catalog: 451606D (Lot serial: 008 1220578); Model Catalog: 451616D (Lot serial: 008 1190373); Model Catalog: 451606D (Lot serial: 008 1190373); Model Catalog: 451616D (Lot serial: 008 1154360); Model Catalog: 54070D (Lot serial: 009 1544263); Model Catalog: 54070D (Lot serial: 009 1450550); Model Catalog: 54070D (Lot serial: 008 1204422); Model Catalog: 54070D (Lot serial: 008 1256851); Model Catalog: 54070D (Lot serial: 009 1377591)
  • 제품 설명
    DPB1 SSP UNITRAY 12 TESTS DPB1 SSP UNITRAY W/TAQ 12 TEST
  • Manufacturer

Manufacturer