Events

Device Recall Captia (TM) Syphilis IgM Capture 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Clark Laboratories, Inc. (dba,Trinity Biotech USA) 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
    69827
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0819-2015
  • 사례 시작날짜
    2014-11-17
  • 사례 출판 날짜
    2014-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131724
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
  • 원인
    Through in-house routine real time stability monitoring of trinity's captia syphilis igm capture test kit, lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
  • 조치
    Recall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.

Device

Device Recall Captia (TM) Syphilis IgM Capture
  • 모델명 / 제조번호(시리얼번호)
    Lot 033, expiry date 30 November 2014
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    New York, Florida, Utah, and California plus foreign distribution to Spain and France
  • 제품 설명
    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
  • Manufacturer
    Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Manufacturer

Clark Laboratories, Inc. (dba,Trinity Biotech USA)
  • 제조사 주소
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Rd, Jamestown NY 14701-9666
  • 제조사 모회사 (2017)
    Trinity Biotech plc
  • Source
    USFDA