Events

Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reaction 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-2015-RN-00463-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00463-1
  • 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
    Due to information received from the field, the potential interference of sulfasalazine and sulfapyridine in the alanine amino-transferase (alt) tests was investigated. the interference through sulfasalazine and sulfapyridine was checked for all tests using nad(h) or nadp(h). this study was done with the following strongly elevated plasma concentrations which correspond to the clsi-guideline ep-7-a2:- 754 µmol/l sulfasalazine (300 mg/l)- 1.2 mmol/l sulfapyridine (299 mg/l)the interference depends on the pharmacokinetic and the clinical status of the patient (e.G. liver and kidney function, bowel resection etc.), which makes it impossible to provide exact information about serum drug concentration and half time.
  • 조치
    Roche is advising laboratories of the potential drug interference. Test instructions for use are in the process of being updated. This action has been closed-out on 11/08/2016.

Device

Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) re...
  • 모델명 / 제조번호(시리얼번호)
    Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reaction All lots affectedARTG: 174906An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited