DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE LIMITED 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
    84423
  • 사례 위험등급
    III
  • 사례 시작날짜
    2014-09-24
  • 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
    Siemens healthcare diagnostics is conducting a field recall for the for dimension vista hba1c and dimension hb1c flex reagent lots listed in section 64(a) of this report. siemens has confirmed that these reagent cartridge lots exhibit a positive bias averaging 0.4% [4.4 mmol/mol] hemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp). qc samples may exhibit a similar bias. as the customer base may differ based on the platform being utilized siemens is issuing two urgent field notices: one ufsn is being issued for the affected lots of dimension vista hemoglobin a1c (hba1c). the second ufsn is being issued for the affected lots of dimension hemoglobin a1c (hb21c). customers will receive the letters pertinent to them. both letters contain the same content differing only in the specified product code and lot numbers.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10483822 (Lot serial: >10 contact mfg.); Model Catalog: DF105A (Lot serial: >10 contact mfg.); Model Catalog: 10470481 (Lot serial: >10 contact mfg.); Model Catalog: K3105A (Lot serial: >10 contact mfg.)
  • 제품 설명
    DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • 제조사 모회사 (2017)
  • Source
    HC