ALLSET GOLD SSP HLA CLASS I HIGH RESOLUTION KITS 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ONE LAMBDA INC 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
    41514
  • 사례 위험등급
    III
  • 사례 시작날짜
    2016-05-18
  • 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
    A false negative reaction may be observed in the presence of a*11:01:04 specifially for primers pm118c pm118f a11-01 and a11-01a. this could lead to mis-typings during analysis.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 541100D (Lot serial: Lot 8 Batch 1441210); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1608939); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1608858); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1472871); Model Catalog: 54310D (Lot serial: Lot 22 Batch 63056); Model Catalog: 541100D (Lot serial: Lot 8 Batch 1608856); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1247232); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1293558); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1306794); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1362561); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1395129); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1428078); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1465433); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1508463); Model Catalog: 54360D (Lot serial: Lot 29 Batch 647); Model Catalog: 54360D (Lot serial: Lot 29 Batch 646); Model Catalog: 54360D (Lot serial: Lot 29 Batch 645); Model Catalog: 54360D (Lot serial: Lot 29 Batch 158
  • 제품 설명
    AllSet Gold SSP HLA Class I High Resolution Kits;AllSet Gold HLA Low Resolution Kits;AllSet Gold ABDRQ Low Resolution Kit;AllSet Gold ABDR Low Resolution Kit;AllSet Gold SSP HLA Direct to High Resolution Kit;AllSet Gold HLA ABC Low - Resolution SSP Kit 10
  • Manufacturer

Manufacturer