VITROS CHEMISTRY PRODUCTS SYSTEM - CREA SLIDES (CREATININE) 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ORTHO-CLINICAL DIAGNOSTICS 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
    104022
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-06-14
  • 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
    Ocd has received an increase in customer complaints related to slide dispense issues with some vitros chemistry products slides. this increase is due to the anti-backup platen (abp) failing to advance inside the vitros chemistry products slide cartridge body causing an increase in condition codes on the vitros system. the abp is a plastic platform that supports the slide stack inside the cartridge and is pushed along with the slides to the top of the cartridge during the slide dispense cycle. if the abp is jammed within the cartridge body a slide will not be properly positioned to dispense and the system will generate a condition code. this can lead to system downtime as the user must remove the cartridge and re-seat the abp in the slide cartridge or replace it with a new cartridge.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 680 2584 (Lot serial: > 10 contact manufacturer); Model Catalog: 1988211 (Lot serial: > 10 contact manufacturer); Model Catalog: 8343386 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801895 (Lot serial: > 10 contact manufacturer); Model Catalog: 1053180 (Lot serial: > 10 contact manufacturer); Model Catalog: 8102204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8001133 (Lot serial: > 10 contact manufacturer); Model Catalog: 8058232 (Lot serial: > 10 contact manufacturer); Model Catalog: 8297749 (Lot serial: > 10 contact manufacturer); Model Catalog: 8159931 (Lot serial: > 10 contact manufacturer); Model Catalog: 1668409 (Lot serial: > 10 contact manufacturer); Model Catalog: 1707801 (Lot serial: > 10 contact manufacturer); Model Catalog: 1921204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8255093 (Lot serial: > 10 contact manufacturer); Model Catalog: 1612365 (Lot serial: > 10 contact manufacturer); Model Catalog: 8383051 (Lot serial: > 10 contact manufacturer)
  • 제품 설명
    VITROS CREA Slides
  • Manufacturer

Manufacturer