Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 module 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty 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
    RC-2017-RN-00853-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-07-11
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Roche has identified that in very rare cases a sample mismatch may occur in specific immunochemistry modules. this issue can only occur if all 5 conditions below are met simultaneously.1. the immunochemistry module is included in its respective system (not standalone); and2. the “module rack buffer setting” ? 1; and3. one rack (rack a) is undergoing sampling and the following rack (rack b) is waiting for measurement; and4. the gripper (t/v carrier) fails to pick up the last vessel on rack a. as a result, the measurement for the sample in the last vessel which failed to be picked up is cancelled and the warning “tips/cup pick up error” (caution level) is issued; and5. sample position 1 of the following rack (rack b) is empty or has no test order for the immunochemistry module.This issue may be detected by 2 alarms occurring within a few minutes of one another: “tip/cup pick up error” (caution level)“abnormal l2-line movement” (s.Stop level).
  • 조치
    Roche Diagnostics is requesting customers follow the detailed instructions given in the Customer Letter and to acknowledge receipt of the communication even if they have no stock which is subject to this recall action.

Device

  • 모델명 / 제조번호(시리얼번호)
    Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 moduleMaterial Number: 04745922001cobas e 602 moduleMaterial Number: 05990378001MODULAR ANALYTICS analyserMaterial Number: 03617505001MODULAR ANALYTICS EVO analyserMaterial Number: 04998642001All software versionsARTG Number: 173887
  • 의료기기 분류등급
  • Manufacturer

Manufacturer