PHADIA 100 SYSTEM - ALLERGENS 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 PHADIA AB 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
    66405
  • 사례 위험등급
    III
  • 사례 시작날짜
    2018-01-02
  • 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
    Somagen diagnostics along with thermofisher scientific would like to notify you of an urgent recall and backorder of immunocap allergen c5 ampicilloyl product code 14-4450-01 and immunocap allergen c6 amoxicilloyl product code 14-4451-01. an internal monitoring stability study has indicated that stability specifications have not been met and were in fact half the intended expiry date of 12 months. there is a possibility that samples with a low positive concentration may be incorrectly reported as negative. any reported test results below the assay limit of qualification (loq) should be disregarded as these results may be invalid. no complaints or injuries to patients have been reported.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 14-4451-01 (Lot serial: 991D7); Model Catalog: 14-4451-01 (Lot serial: 991DC); Model Catalog: 14-4451-01 (Lot serial: 991DB); Model Catalog: 14-4451-01 (Lot serial: 991D8); Model Catalog: 14-4451-01 (Lot serial: 991D9); Model Catalog: 14-4450-01 (Lot serial: 990DT); Model Catalog: 14-4450-01 (Lot serial: 990DS); Model Catalog: 14-4450-01 (Lot serial: 990DU); Model Catalog: 14-4450-01 (Lot serial: 990DV); Model Catalog: 14-4451-01 (Lot serial: 991DA); Model Catalog: 14-4450-01 (Lot serial: 990DX); Model Catalog: 14-4450-01 (Lot serial: 990DY); Model Catalog: 14-4450-01 (Lot serial: 990DZ); Model Catalog: 14-4450-01 (Lot serial: 990DW)
  • 제품 설명
    ImmunoCAP Allergen c6 Amoxicilloyl;ImmunoCAP Allergen c5 Ampicilloyl
  • Manufacturer

Manufacturer