PHADIA 250 SYSTEM - INSTRUMENT REAGENTS 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
    24248
  • 사례 위험등급
    II
  • 사례 시작날짜
    2017-03-06
  • 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
    There have been reports of instrument malfunctions for phadia 250 due to deformed bottles in the below mentioned products and lots. the deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent thus generating insufficient dilution of patient samples. the deformation is described as a flange or brim located on the inside lower part of the vial opening. the instrument malfunction due to deformed bottles could cause erroneous test results mainly false positive with regard to all elia assays and mainly falsely increased test results for immunocap total ige and immunocap igg4/igg assays. the frequency of this bottle defect is very low and not every defective bottle will cause the error. an instrument malfunction caused by deformed bottles will generate the instrument error message "3-145 right arm liquid detection below lower limit with target 2". it is important that you review your records for the above mentioned error message.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 83-1023-01 (Lot serial: JM3Y); Model Catalog: 83-1023-01 (Lot serial: JS0B); Model Catalog: 83-1023-01 (Lot serial: JP87); Model Catalog: 83-1023-01 (Lot serial: JK5N); Model Catalog: 83-1023-01 (Lot serial: JU9C)
  • 제품 설명
    EliA Sample Diluent
  • Manufacturer

Manufacturer