Events

Device Recall Captia Measles IgM 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
    74932
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2782-2016
  • 사례 시작날짜
    2016-07-11
  • 사례 출판 날짜
    2016-09-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148847
  • 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 immunoabsorbent assay, rubeola IgM - Product Code PCL
  • 원인
    The product lot failed to meet qc acceptance criteria during stability testing. the calibrator od was dropping causing the positive control to be invalid (running high out of range).
  • 조치
    Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.

Device

Device Recall Captia Measles IgM
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 2326060-043, Expiration Date 31 May 2017
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution to US nationwide including California, and China (Hong Kong).
  • 제품 설명
    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
  • 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