Events

Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories Pty Ltd 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-2018-RN-00495-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00495-1
  • 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
    Bio-rad have received multiple customer complaints indicating that some analyte values in certain vials of liquichek urine chemistry control level 2, lot 68512, are recovering outside the package insert stated ranges, namely high cvs.The performance of level 1, lot 68511 is not impacted.To date, there have been no reports of injury or illness as a result of this issue.
  • 조치
    Bio-Rad is advising customers to inspect and quarantine affected units to prevent further use. Customers are advised to discard any remaining inventory of Liquichek Urine Chemistry Control, Level 2 Lot 68512 and MiniPak 395X Lot 68510 (that contains the level 2). Users are advised to contact Bio-Rad to make arrangements for replacement or to alter any pending orders or shipments. The replacement stock of Liquichek Urine Chemistry Control Level 2 is Lot 65822.

Device

Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains...
  • 모델명 / 제조번호(시리얼번호)
    Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). An in vitro diagnostic medical device (IVD)Liquichek Urine Chemistry Control Level 2Catalogue Number: 398Lot Number: 68512Expiry Date: 30 Sept 2019Liquichek Urine Chemistry Control MiniPak (contains Level 2)Catalogue Number: 395XLot Number: 68510Expiry Date: 30 Sept 2019ARTG Number: 206309(Bio-Rad Laboratories - Clinical chemistry biological screening IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd